Import Alert 53-17

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 53-17
Published Date: 09/06/2023
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 05/16/2023 updates the guidance section including agency contacts. Changes to the import alert are bracketed by asterisks (***).

This import alert has been developed for specific firms that have offered cosmetics with microbiological contamination and have met the criteria for detention without physical examination (DWPE) as established in FDA's Regulatory Procedures Manual (RPM) Chapter 9.

Cosmetic products must be safe for the consumer when used according to direction on the label or in the customary or expected way. They must also not be prepared, packed, or stored in a way in which they may become contaminated or harmful to health. This includes, for example, making sure cosmetics are free of harmful microorganisms. Cosmetic products must be completely free of high-virulence microbial pathogens, and the total number of aerobic microorganisms per gram must be low.

Guidance:

Divisions may detain, without physical examination, shipments of specified products from firms identified in the Red List of this import alert.

In accordance with Chapter 9 of the Regulatory Procedures Manual, recommendations for addition to DWPE for specific product(s) from an individual firm may be made after one violative entry and all other appropriate criteria are satisfied.

Recommendations for additions to the Red List of this import alert will be evaluated by the Division of Import Operations (DIO) and the Center for Food Safety and Applied Nutrition (CFSAN).

Release of Articles Subject to DWPE under This Import Alert:

*** In order to secure release of an individual shipment subject to detention without physical examination under this alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product does not bear or contain microbiological contamination that would render the product violative. Such evidence could include private laboratory analysis of a representative sample(s) collected from the affected article. A representative sample should consist of a minimum of 5 sub-samples (e.g., 5 retail units, or collections of retail units, if the net weight of a single retail unit is insufficient for analysis).

Evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, Volume III, Section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.***

Removal from DWPE (REMOVE FROM RED LIST):

In order to remove a firm's product from the Red List, information including satisfactory microbiological testing results from a third-party laboratory analysis of a representative sample of the detained product in each of the five consecutive shipments should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of a violation and microbial contamination that would render the product violative. The purpose of this is so the agency will have confidence that future entries will be in compliance with the FD&C Act. For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)"

If a firm and/or a representative thereof would like to petition for removal from DWPE under this import alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or, be sent via email to: Importalerts2@fda.hhs.gov

Questions or issues involving import operations should be addressed to the Division of Import Operations at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov.

*** Questions or issues with regard to human food on policy, sample collection recommendations, or other any additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov***

                                                                                                                                                                        

Product Description:

Cosmetics

Charge:

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the cosmetic appears to bear or contain a poisonous or deleterious
substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or
usual[Adulteration, Section 601(a)]

OASIS charge code: POISONOUS

AND/OR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be an ingredient in a cosmetic product and may have been prepared packed or held under
insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health. [Adulteration, Section 601(c)]

OASIS charge code: COSMETIC

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


BELGIUM


Laboratoires Ndv
Date Published : 04/13/2012
B 1930 Zaventen , Brixtonlaan, BELGIUM
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/13/2012

Desc: Nelly De Vust Slimming Oil
Notes: Staphyloccus xylosus


CANADA


Apollo Nutraceuticals Inc
Date Published : 03/14/2011
20 Graniteridge Rd , Concord, ON CANADA
53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 03/14/2011

Desc: Daily Skin Facial Scrub
Notes: 601(a) Staphylococcus Hominis

Demco Manufacturing Inc
Date Published : 09/18/2009
5485 Ramsay , Saint-Hubert, QC CANADA
53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes)
Date Published: 03/29/2021

Desc: Crayon Face Paint Markers
Notes: 601(a);Yeast/mold;viable gram positive rods ; 8/9/07

53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes)
Date Published: 09/18/2009

Desc: Crayon Face Paint Markers;8/9/07
Notes: 601(a);Yeast/mold;viable gram positive rods

53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 09/18/2009

Desc: Crayon Face Paint Markers;8/9/07
Notes: 601(a); yeast/mold; viable gram postive rods

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc: Crayon Face Paint Markers;8/9/07
Notes: 601(a); Yeast/mold; viable gram positive rods

Estee Lauder
Date Published : 07/20/2011
217 Idema Rd , Markham, ON CANADA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 07/20/2011

Desc: MAC Double Feature 4 Tealdrop (WN)/Original Ochre (WN) Eyeshadow
Notes: 601 (a) Sphingomonas; paucimobilis;shewanella putrefaciens

Evergreen Consumer Brands Ulc
Date Published : 01/13/2015
100 Delta Park Blvd , Brampton, Ontario CANADA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 01/13/2015

Desc: Spa Haus Aqua Bold Shower Gel for Men
Notes: Problem(s); Various Gram-positive cocci and Gram-negative rods; including opportunistic pathogens Note; 601(a) Opportunistic pathogens; Acinetobacter lwoffii and Sphingomonas paucimobilis

Golden Moor
Date Published : 02/16/2011
38 Indsutiral , Casselman, Ontario CANADA
53 B D - 99 Other Bath Preparations, N.E.C., Liquid, Lotion
Date Published: 06/02/2011

Desc: Bain de Boue (Mud Bath)
Notes: 601(a) Enteroccus faecalis Pseudmonas putida Stenotrophomonas maltophilia Enterobacter amnigenus Acinetobacter radioresistens

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 02/16/2011

Desc: Natural Face Mask
Notes: Pseudomonas Fluorescens

ITN Food
Date Published : 01/13/2015
40 Commander Boulevard , Toronto, ON CANADA
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 01/13/2015

Desc: Ubtan Powder
Notes: Mold Gram-negative organisms; Gram-positive organisms; Gram-positive cocci;

Laboratoires Bio Botanical, Inc.
Date Published : 09/18/2009
22200 Aut Transcanadienne , Baie-d'Urfe, Quebec CANADA
53 A D - 01 Baby Shampoo (Baby Products), Liquid, Lotion
Date Published: 05/20/2011

Desc: Lil Goat's Milk Shampoo and Body Wash
Notes: 601 (a) Enterobacter gergoviae

53 A - - 02 Lotions, Oils, Powders and Creams (Baby Products)
Date Published: 03/29/2021

Desc: Li'l Goat's Moisturing Lotion
Notes: Milk 601(a) gram negative rods and Enterobacter gergoviae; 6/15/2010

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 03/29/2021

Desc: Shampoo (Clearly Natural Brand)
Notes: 601(a)/Pseudomonas, aeruginosa; 6/18/2003

Les Productions Pupazzo
Date Published : 01/25/2013
788 Avenue Greene , Montreal, QUEBEC CANADA
53 A - - 02 Lotions, Oils, Powders and Creams (Baby Products)
Date Published: 01/25/2013

Desc: Pupazzo Soothing face & Body Milk (Delicate Fragrance)
Notes: 601(a) P. aeruginosa

Mistura Beauty
Date Published : 08/27/2015
5350 Canotek Rd Unit 7 , Gloucester, ON CANADA
53 G - - 02 Face Powders (Makeup Preparations, not for Eyes)
Date Published: 08/27/2015

Notes: Mineral Based Powder Six in One Cosmetic Powder (Eliminates need for foundation; concealer; blush; bronzer; lipstick; & eye shadow; 6 in 1);NOTE:                                                                                                                                        ;Problem(s); Staphylococcus warneri ; Staphylococcus pasteuri;9/2/2015

53 G - - 03 Foundations (Makeup Preparations, not for Eyes)
Date Published: 03/29/2021

Notes: Mineral Based Powder Six in One Cosmetic Powder (Eliminates need for foundation; concealer; blush; bronzer; lipstick; & eye shadow; 6 in 1); NOTE:                                                                                                                                     ;Problem(s); Staphylococcus warneri ; Staphylococcus pasteuri; 9/2/2015

53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes)
Date Published: 08/27/2015

Notes: Mineral Based Powder Six in One Cosmetic Powder (Eliminates need for foundation; concealer; blush; bronzer; lipstick; & eye shadow; 6 in 1); NOTE:                                                                                                                                       ;Problem(s); Staphylococcus warneri ; Staphylococcus pasteuri;9/2/2015

Neuco
Date Published : 12/09/2013
1899 Lionel Bertrand , Boisbriand, QUEBEC CANADA
53 A - - 01 Baby Shampoo (Baby Products)
Date Published: 12/09/2013

Desc: Green Babies Tearless Baby Me Shampoo & Wash
Notes: 601(a) Staphylococcus spp.


CHINA


Beauty Vision Ltd.
Date Published : 06/23/2011
Blk.c,bao Tong Ind.dist.tong Mei Village , Gong Ming Town,bao An County, , Shenzhen, CN-44 CHINA
53 C H - 03 Eye Shadow (Eye Makeup Preparations), Powder
Date Published: 06/23/2011

Desc: Eye Shadow and Lip-Gloss (Contained in Bratz Makeup Design Sketch Book)
Notes: 601(a) Staphylococcus intermedius; Staphylococcu warneri; Gram Positive Coccus

53 G K - 06 Makeup Bases (Makeup Preparations, not for Eyes), Sticks
Date Published: 06/23/2011

Desc: Eye Shadow and Lip-Gloss (Contained in Bratz Makeup Design Sketch Book)
Notes: 601(a) Staphylococcus intermedius; Staphylococcu warneri; Gram Positive Coccus

Elle Jewelry Corp
Date Published : 09/18/2009
37-3 Nong Gong Road Yiwu , Zhejiang, CHINA
53 C - - -- Eye Makeup Prep
Date Published: 03/29/2021

Desc: Lip.eye line pencil
Notes: 601(c);CHRYSEOMONAS : LUTEOLA; PSEUDOMONAS : NOT SPECIATED;3/31/03

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc: lip/eye liner pencil; 3/31/03
Problems: CHRYSEOMONAS : LUTEOLA; PSEUDOMONAS : NOT SPECIATED;

Fujian Ishine Cosmetics Co., Ltd.
Date Published : 03/19/2015
Erji Road , Zhenghe Industrial Zone , Nanping, Fujian CHINA
53 C - - 02 Eyeliner (Eye Makeup Preparations)
Date Published: 03/19/2015

Desc: LUV@KISS/ Multifunctional Eyeliner
Notes: Problem(s); Microbiological Contamination Note; Product (Glitter Eyeliner) presents a safety concern due to the presence of microorganisms in excess of 500 CFU/gram.

HEMAO COSMETICS HUIZHOU CO LTD
Date Published : 07/31/2023
Xinqu Nansan Road Zhong , Huizhou, CHINA
53 C - - 01 Eyebrow Pencil (Eye Makeup Preparations)
Date Published: 07/31/2023

Desc: L.A. Colors Mascara Eye/Brow Pencil & Sharpener/Mascara Crayon-CBC121 Black
Notes: Aspergillus brasiliensis, Bacillus cereus, Bacillus lichenformis, Bacillus simplex, Brevibacillus choshinensis, Chaetominum globosum, motile, spore-forming gram positive rods, Paenibacillus glucanolyticus and Paenibacillus tundrae, were identified in the sample.

53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 07/31/2023

Desc: L.A. Colors Mascara Eye/Brow Pencil & Sharpener/Mascara Crayon-CBC121 Black
Notes: Aspergillus brasiliensis, Bacillus cereus, Bacillus lichenformis, Bacillus simplex, Brevibacillus choshinensis, Chaetominum globosum, motile, spore-forming gram positive rods, Paenibacillus glucanolyticus and Paenibacillus tundrae, were identified in the sample.

53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations)
Date Published: 07/31/2023

Desc: L.A. Colors Mascara Eye/Brow Pencil & Sharpener/Mascara Crayon-CBC121 Black
Notes: Aspergillus brasiliensis, Bacillus cereus, Bacillus lichenformis, Bacillus simplex, Brevibacillus choshinensis, Chaetominum globosum, motile, spore-forming gram positive rods, Paenibacillus glucanolyticus and Paenibacillus tundrae, were identified in the sample.

Hainan Fuwang Industrial Co., Ltd.
Date Published : 03/24/2017
Room 9b , Beijing Bldg A6 Garden Financial; Haikou , Hainansheng, Hainan CHINA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 03/24/2017

Desc: Peppermint Scrub
Problems: BACILLUS : PUMILUS; BACILLUS : NOT SPECIATED;

Her Maow Cosmetics
Date Published : 06/06/2013
Guang He Ind. 6 , Th Area , Hui Zhou City, Guandong CHINA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 06/06/2013

Desc: Eye Shadow Hard Candy 10 Well Compact
Notes: 601(a);Bacillus spp.;Lysinibacillus ssp;Staphylococcus lentus; Staphylococcus xylosus; Pseudomonas psedoalcaligenes; kocuria varians

53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 06/06/2013

Desc: Brow Powder Taupe
Notes: 601(a); B.cereus/thuringiensis/mycoides;B.lentus;B pumilus; Brevibacillus choshinensis

Jinhua Aoshiya Cosmetics Co Ltd
Date Published : 05/09/2023
# 1666 Shenli Rd Jinhua Econ & Tech , Jinhua, Zhejiang CHINA
53 G - - 10 Children Novelty Face Makeup Kits
Date Published: 05/09/2023

Desc: LOL Surprise! Remix Cosmetic Set
Notes: Staphylococcus warneri, Staphylococcus epidermidis, Kocuria spp., Gram-positive rods, and elevated levels of bacteria were identified in the sample.

Jinmei Co Ltd
Date Published : 05/05/2015
No 82 Luhu East Rd , Qingxi Town , Dongguan City, Guangdong CHINA
50 N - - 99 Colors For Cosmetic Use (Not Certified), N.E.C.
Date Published: 05/22/2017

Desc: Body Paint/Pigment
Notes: Problem(s); Gram Positive Rods Gram Negative Rods Endotoxins; 601(a) Contaminated with microorganisms

Johns Cosmetic
Date Published : 09/18/2009
Li Lang Da Dao , Shenzhen, CHINA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Multi-use Eye Shadow; 3/15/05
Notes: 601(a); gram positive and negative bacteria
Problems: CITROBACTER; STAPHYLOCOCCUS : AUREUS;

53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Multi-use Eye Shadow; 3/15/05
Notes: 601(a); gram pos and neg bacteria
Problems: CITROBACTER; STAPHYLOCOCCUS : AUREUS;

Maanshan Yingkai International Trading Co. Ltd.
Date Published : 04/24/2017
Tangnan, Dangtu , Maanshan City, CHINA
53 C - - 99 Other Eye Makeup Preparations, N.E.C.
Date Published: 04/24/2017

Desc: Day & Night False Eyelashes and Glue Set
Notes: 601(a); high aerobic plate count reported as Bacillus coagulans
Problems: BACILLUS : COAGULANS;

53 C - - 99 Other Eye Makeup Preparations, N.E.C.
Date Published: 04/24/2017

Desc: Batta Lash False Eyelashes and Glue Set
Notes: 601(a); high aerobic plate count reported as Bacillus coagulans
Problems: BACILLUS : COAGULANS;

NICE HARVEST PLASTIC ENTERPRISE
Date Published : 01/25/2017
NO. 16 Putuoshan Road , Beilun District , Ningbo, CHINA
53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations)
Date Published: 01/25/2017

Desc: Brows (eye cosmetic kit)
Notes: Bacillus spp. (a group of Bacillus species due to low discrimination) B. licheniformis
Problems: BACILLUS;

Ningbo Hiking Imp & Exp Co., Ltd.
Date Published : 09/18/2009
Room 2209 , 139 Yaohank Street , Ningbo, CHINA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Le Le Make up set; 1/25/07
Notes: 601(a)
Problems: PSEUDOMONAS : AERUGINOSA;

53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Le Le Make-up Set; 1/25/07
Notes: 601(a)
Problems: PSEUDOMONAS : AERUGINOSA;

Ningbo Kangsheng Print Pack
Date Published : 07/27/2016
No. 19 Jinsi Road , Ningbo, CHINA
53 G - - 11 Children Novelty Body Paints
Date Published: 07/27/2016

Desc: Tattoo Pens
Notes: Bacillus smithii; Bacillus simplex; Bacillus fortis; Paenibacillus glucanolyticus; Candida pelliculosa; were also identified.
Problems: BACILLUS : MEGATERIUM; ENTEROCOCCUS : CASSELIFLAVUS; BACILLUS : PUMILUS;

SanYuanSu Cosmetics Factory
Date Published : 02/03/2016
27344 District H International , Reade Center , Yiwu, ZheJiang CHINA
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 02/03/2016

Desc: Diamond Mascara
Notes: Problem: Achromobacter xylosoxidans
Problems: PSEUDOMONAS : PUTIDA; BACILLUS : LENTUS;

Shanghai Color Art Stationery Company Limited
Date Published : 09/30/2009
85 Xingchuansha Road , Loujing, Boashan , Qu Shanghai, CHINA
53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes)
Date Published: 09/30/2009

Desc: Face and Body Paints
Notes: 601 (a) Yeast/Mold Gram Positive Rods High Aerobic Plates Counts 7/15/09

Shenzhen Yada Cosmetics Co Ltd
Date Published : 09/18/2009
4/F 02 Bld Fuzhao Center Buxin Rd , Shenzhen, CHINA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Eye Shadow; 7/14/03
Notes: 601(c)
Problems: PSEUDOMONAS; CHRYSEOMONAS;

VEGAR COSMETICS
Date Published : 06/08/2018
5f No 12 Taian Rd Yuntiindustry Area , Fengxin St Chaozhou , Guangdong, CHINA
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 06/08/2018

Desc: Simply Mascara
Notes: BREVIBACILLUS CHOSHINENSIS
Problems: BACILLUS : PUMILUS; BACILLUS : NOT LISTED, IDENTIFY IN REMARKS;

XIAMEN ROYAL BATH ACCESSORIES CO.,LTD
Date Published : 09/18/2009
# 2135 Yanshen Duan Huli Dadao , Zhongzhai Country Huli Xiamen China , Xiamen, CHINA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: 4/14/08
Notes: 601(a) high aerobic plate count identified as Stenotrophomonas maltophilia (Pseudomonas)
Problems: PSEUDOMONAS : MALTOPHILIA;

Xiamen Royal Bath Accessories Co
Date Published : 09/18/2009
No#5 Building,Pan Tu Ind.Estate , Xiamen Citychina, CHINA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: 4/14/08
Notes: 601(a); high aerobic plate count identified as Stenotrophomonas maltophilia (Pseudomonas)
Problems: PSEUDOMONAS : MALTOPHILIA;

Yiwu City Ludanmei Cosmetics Co. Ltd.
Date Published : 06/06/2013
Yidong Niansanli , NO. 15 Niansanli Jiedao WuyanbeiluZHEJIA , Jinhua, Zhejiang CHINA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 06/06/2013

Desc: Eye Shadow
Notes: 601(a);Paenibacillus amylolyticus Paenibacillus polymyxa

Yiwu Mingyun Cosmetic Co Ltd
Date Published : 08/17/2016
No 98 Xiangyi Rd Yiting , Yiwu City, CHINA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 08/17/2016

Desc: Triple Crown Baked Shadow Blue Hawaii (Eye Shadow)
Notes: Gram positive; coagulase negative cocci
Problems: BACILLUS : LICHENIFORMIS; ENTEROCOCCUS : FAECIUM; BACILLUS : THURINGIENSIS; BACILLUS : PUMILUS;

ZHEJIANG GOLDEN LOTUS IMPORT/EXP
Date Published : 04/20/2023
Rm 2904 , NO 1107 Tianton; District, Nin , Yinshan, CHINA
53 C H - 03 Eye Shadow (Eye Makeup Preparations), Powder
Date Published: 04/20/2023

Desc: Eye Shadow; Chameleon Metallic Eye Shadow; 9Holo Green Shadow
Notes: Elevated level of bacteria, yeasts, and molds.

Zhejiang Mingzhuang Cosmetics Co., Ltd
Date Published : 02/03/2016
222#, Changfeng North Street, Jindong , Zhejiang, CHINA
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 02/03/2016

Desc: Kleancolor Bowtux lash mascara
Notes: 601(a) Contaminated with microorganisms
Problems: BACILLUS : CEREUS; STAPHYLOCOCCUS : WARNERI; STAPHYLOCOCCUS : EPIDERMIDIS;

Zhejiang Pure Essential Cosmetic Co., Ltd.
Date Published : 05/26/2020
No. 92 Qiuling Road , Economic Development Zone , Lanxi, Zhejiang CHINA
53 G - - 02 Face Powders (Makeup Preparations, not for Eyes)
Date Published: 05/26/2020

Desc: HIGHLIGHT & EYESHADOWS PALETTE
Notes: Bacillus species, including B. cereus.

Zhejiang Yasili Cosmetics Co., Ltd.
Date Published : 09/18/2009
Chouyi West Rd , No. 163 Yiting; Yitingzhen Yiwu , Jinhua, Zhejiang CHINA
53 C - - 01 Eyebrow Pencil (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Eye Pencil; 3/1/05
Notes: 601(a); non spore forming gram pos rods; coagulase neg and gram pos cocci; gram neg rods
Problems: ACINETOBACTER; PSEUDOMONAS;

53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: 3/1/05
Notes: 601(a); non spore forming gram pos rods; coagulase neg and gram pos cocci; gram neg rods
Problems: PSEUDOMONAS; ACINETOBACTER;

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc: eye shadow; eye pencil; cream eye shadow; 3/1/05
Notes: 601(a); non spore forming gram pos rods; coagulase neg and gram pos cocci; gram negative rods
Problems: PSEUDOMONAS; ACINETOBACTER;

Zhongshan Metro Cosmetics Ind Co Lt
Date Published : 09/18/2009
No 1 Shunming St , Zhongshan City, CHINA
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc: Cosmetic Sets; 3/31/03
Notes: 601(c); multiple micro contamination; unidentified gram neg non-fermenters; Actinobacillus ureae; Shingomonas paucimobilis
Problems: ACINETOBACTER : JUNII; ACINETOBACTER : LWOFFI; ACTINOBACILLUS : NOT LISTED, IDENTIFY IN REMARKS; AGROBACTERIUM : RADIOBACTER; STAPHYLOCOCCUS : AURICULARIS; OCHROBACTRUM : ANTHROPI; PASTEURELLA : HAEMOLYTICA; PHOTOBACTERIUM; CHRYSEOMONAS : LUTEOLA;

Zhuhai Maxis Cosmetics Prod.Co. Ltd
Date Published : 09/18/2009
6e Nanxi Industry District #A2 , Qinshan, , Zhuhai City, Guangdong CHINA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Eye Shadow Kit; 7/14/03
Notes: 601(c); multiple micro contamination; Sphingomonas paucimobilis
Problems: ACINETOBACTER : JUNII; ACINETOBACTER : LWOFFI; PASTEURELLA : TREHALOSI; PASTEURELLA : HAEMOLYTICA; PASTEURELLA : MULTOCIDA; CHRYSEOMONAS : LUTEOLA;


CURACAO


ATM, Inc. (Curacao)
Date Published : 09/18/2009
Curazao Free Zone , Maduro Plaza , Willemstad, CURACAO
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 09/18/2009

Desc: Pantene hydrating curls (counterfeit); 11/5/04
Notes: 601(a)
Problems: PSEUDOMONAS : AERUGINOSA;


DOMINICAN REPUBLIC (THE)


Rey Fruit S R L
Date Published : 01/26/2016
Zona Franca Puerto Plata Nave A-7 , Puerto Plata, Zona Franpuerto Plata, Zon, DOMINICAN REPUBLIC (THE)
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 01/26/2016

Desc: Exfoliating Cream
Notes: Problem(s); STAPHYLOCOCCUS INTERMEDIUS; STAPHYLOCOCCUS LENTUS; STAPHYLOCOCCUS AUREUS; BACILLUS LENTUS; BACILLUS PUMILUS; BACILLUS LICHENIFORMIS; BACILLUS VALLISMORTIS; BREVBACILLUS CHOSHINENSIS; LYSINBACILLUS


FRANCE


Vitry Sa
Date Published : 01/06/2011
Pa De La Foret , Bignon, FRANCE
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 01/06/2011

Desc: Longcils Boncza Cake Mascara Black
Notes: 601(a) Gram Positive rods non-sporeforming


GERMANY


Inspira Cosmetics Gmbh
Date Published : 12/21/2016
Hirzenrott 13 , Aachen, North Rhine-Westphalia GERMANY
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/21/2016

Desc: Peel Off Alginate Bio Marine Extract
Notes: BACILLUS FIRMUS; BREVIBACILLUS CHOSHINESSIS; GEOBACILLUS TOEBII; BACILLUS CIRCULANS; BACILLUS AMYLOLIQUIFACIENS; BACILLUS ATROPHAEUS;
Problems: BACILLUS : CEREUS; BACILLUS : MYCOIDES; STAPHYLOCOCCUS : LENTUS; BACILLUS : THURINGIENSIS; STAPHYLOCOCCUS : AUREUS; BACILLUS : SUBTILIS;


GHANA


Banbara Enterprises Limited
Date Published : 04/23/2015
P O Box 7789 , Accra, GHANA
53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 04/23/2015

Desc: Cryptolepsis Sanguiolenta roots; dried & powdered- bulk ingredient for cosmetic products
Notes: Problem(s); Pseudomonas aeruginosa

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/23/2015

Desc: Cryptolepsis Sanguiolenta roots; dried & powdered- bulk ingredient for cosmetic products
Notes: Problem(s); Pseudomonas aeruginosa


INDIA


CUCKU ENTERPRISES PVT. LTD.
Date Published : 05/15/2013
G - 12 , Delhi, Delhi INDIA
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 05/15/2013

Desc: Herbal Neem Powder
Notes: 601(c)Patoea spp.; B. licheniformis; B. curculans; and B. vallismortis

SHREE SADGURU MASALA & SPICES INDUSTRIES PVT.LTD.
Date Published : 04/04/2017
A -231.T.T.C.INDUSTRIAL AREA,M.I.D.C , MAHAPE,NAVI MUMBAI-400708 , Mumbai (navi Mumbai), Maharashtra INDIA
53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati
Date Published: 04/04/2017

Desc: Color Marathon Holi Colors
Notes: The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie;
Problems: BACILLUS : CEREUS; BACILLUS : MYCOIDES; BACILLUS : PUMILUS; BACILLUS : THURINGIENSIS; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; STAPHYLOCOCCUS : LENTUS;

53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes)
Date Published: 04/04/2017

Desc: Color Marathon Holi Colors
Notes: The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie;
Problems: BACILLUS : PUMILUS; STAPHYLOCOCCUS : LENTUS; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; BACILLUS : THURINGIENSIS; BACILLUS : MYCOIDES; BACILLUS : CEREUS;

53 G - - 11 Children Novelty Body Paints
Date Published: 04/04/2017

Desc: Color Marathon Holi Colors
Notes: The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie;
Problems: BACILLUS : CEREUS; BACILLUS : MYCOIDES; STAPHYLOCOCCUS : LENTUS; BACILLUS : PUMILUS; BACILLUS : THURINGIENSIS; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS;

53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 04/04/2017

Desc: Color Marathon Holi Colors
Notes: The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie;
Problems: BACILLUS : MYCOIDES; BACILLUS : CEREUS; BACILLUS : PUMILUS; BACILLUS : THURINGIENSIS; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; STAPHYLOCOCCUS : LENTUS;

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 04/04/2017

Desc: Color Marathon Holi Colors
Notes: The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie;
Problems: STAPHYLOCOCCUS : LENTUS; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; BACILLUS : THURINGIENSIS; BACILLUS : PUMILUS; BACILLUS : MYCOIDES; BACILLUS : CEREUS;

Shree Sadguru Tea Agency
Date Published : 04/04/2017
72/A Gunj Bazzaar , Nadiad, Gujarat INDIA
53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati
Date Published: 04/04/2017

Desc: Color Marathon Holi Colors
Notes: The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie
Problems: BACILLUS : CEREUS; BACILLUS : MYCOIDES; BACILLUS : PUMILUS; BACILLUS : THURINGIENSIS; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; STAPHYLOCOCCUS : LENTUS;

53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes)
Date Published: 04/04/2017

Desc: Color Marathon Holi Colors
Notes: The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie
Problems: BACILLUS : PUMILUS; STAPHYLOCOCCUS : KLOOSII; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; BACILLUS : THURINGIENSIS; BACILLUS : MYCOIDES; BACILLUS : CEREUS;

53 G - - 11 Children Novelty Body Paints
Date Published: 04/04/2017

Desc: Color Marathon Holi Colors
Notes: The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie
Problems: BACILLUS : CEREUS; BACILLUS : MYCOIDES; STAPHYLOCOCCUS : KLOOSII; BACILLUS : PUMILUS; BACILLUS : THURINGIENSIS; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS;

53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 04/04/2017

Desc: Color Marathon Holi Colors
Notes: The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie
Problems: BACILLUS : MYCOIDES; BACILLUS : CEREUS; BACILLUS : PUMILUS; BACILLUS : THURINGIENSIS; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; STAPHYLOCOCCUS : KLOOSII;

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 04/04/2017

Desc: Color Marathon Holi Colors
Notes: The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie
Problems: STAPHYLOCOCCUS : KLOOSII; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; BACILLUS : THURINGIENSIS; BACILLUS : PUMILUS; BACILLUS : MYCOIDES; BACILLUS : CEREUS;


INDONESIA


PT Surya Garutindah (Perseroan Terbatas)
Date Published : 02/02/2010
JL Pataruman , No. 47 Garut 44151 , Jawa Barat, INDONESIA
53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations)
Date Published: 08/28/2010

Desc: All Eyelash Kits (With and without Glue)
Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10

53 C - - 99 Other Eye Makeup Preparations, N.E.C.
Date Published: 08/28/2010

Desc: All Eyelash Kits (With and without Glue)
Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/28/2010

Desc: All Eyelash Kits (With and without Glue)
Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10


ITALY


Gamma Croma S.P.A.
Date Published : 09/18/2009
Km 29 , Strada Statale Paullese 415 , Vaiano Cremasco, Cremona ITALY
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Notes: Eye shadow
Problems: STAPHYLOCOCCUS : HOMINIS; BACILLUS : CEREUS;


KOREA (THE REPUBLIC OF)


Ens
Date Published : 02/03/2016
501 Hanam Venture Center 239 , Gyenonggi-do, KOREA (THE REPUBLIC OF)
53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 02/03/2016

Desc: Green Essence Lifting Facial Mask Pack
Problems: BACILLUS : CEREUS;

Gc Logistics Corporation
Date Published : 06/16/2014
501 Lohas Ave , Hwaseong, KOREA (THE REPUBLIC OF)
53 C - - 99 Other Eye Makeup Preparations, N.E.C.
Date Published: 06/16/2014

Desc: Eye Toner Panda's Dream Eye Patch
Notes: Problem; Gram-positive cocci

Greenb Cosmetic Co. Ltd.
Date Published : 06/04/2014
147 Block 8 Namdong Industrial Complex , 713-16 Gojan-Dong , Incheon, KOREA (THE REPUBLIC OF)
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 06/04/2014

Desc: Mascara
Notes: Candida pelliculosa Aerobic plate count Yeast and Mold
Problems: STAPHYLOCOCCUS : AUREUS; CANDIDA;

H & K Korea Corp.
Date Published : 01/18/2013
No. 307 3f Woori Bldg. 47-17 Sin , Seoul, KOREA (THE REPUBLIC OF)
53 C - - 04 Eye Lotion (Eye Makeup Preparations)
Date Published: 01/18/2013

Desc: Hydrogel Eye Patch
Notes: 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis.

53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations)
Date Published: 01/18/2013

Desc: Hydrogel Eye Patch
Notes: 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis.

53 C - - 99 Other Eye Makeup Preparations, N.E.C.
Date Published: 01/18/2013

Desc: Hydrogel Eye Patch
Notes: 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 01/18/2013

Desc: Hydrogel Eye Patch
Notes: 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/18/2013

Desc: Hydrogel Eye Patch
Notes: 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/18/2013

Desc: Hydrogel Eye Patch
Notes: 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis.

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 01/18/2013

Desc: Hydrogel Eye Patch
Notes: 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis.

Pacific Corporation
Date Published : 09/18/2009
CPO Box 195 , Seoul, KOREA (THE REPUBLIC OF)
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: eye shadow; 5/16/95
Notes: 601(a)
Problems: PSEUDOMONAS : STUTZERI;

Seowoo Int Corp
Date Published : 02/02/2010
229 Chungjeon Rezion 465 , 3-ga Chungjeong-ro, Seodaemun-gu , Seoul, KOREA (THE REPUBLIC OF)
53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations)
Date Published: 08/28/2010

Desc: All Eyelash Kits (With and without Glue)
Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10

53 C - - 99 Other Eye Makeup Preparations, N.E.C.
Date Published: 04/01/2021

Desc: All Eyelash Kits (With and without Glue)
Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/28/2010

Desc: All Eyelash Kits (With and without Glue)
Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10

TONYMOLY Co., Ltd.
Date Published : 06/16/2014
180 Bangbae-ro , Seoco-gu, Seoulteugbyeol-si KOREA (THE REPUBLIC OF)
53 C - - 99 Other Eye Makeup Preparations, N.E.C.
Date Published: 06/16/2014

Desc: Eye Toner Panda's Dream Eye Patch
Notes: Gram-positive cocci

VOTRE COSMETIC CO,. LTD
Date Published : 02/07/2020
71 Mayu-Ro 186 Beon-Gil , Gyeonggi-Do, KOREA (THE REPUBLIC OF)
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 02/07/2020

Desc: Mascara Falscara
Notes: Violative for APC and Yeast & Mold


MEXICO


Baja Fur S A De C V
Date Published : 02/02/2010
Calle Romano 1352 , Tijuana, MEXICO
53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations)
Date Published: 08/28/2010

Desc: ALl Eyelash Kits (With and without Glue)
Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10

53 C - - 99 Other Eye Makeup Preparations, N.E.C.
Date Published: 08/28/2010

Desc: All Eyelash Kits (With and without Glue)
Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/28/2010

Desc: All Eyelash Kits (With and without Glue)
Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10

Christian Cosmetics
Date Published : 06/18/2014
Calle Ensenada #394, Sec. Triangulo De , Tijuana, MEXICO
53 C H - 03 Eye Shadow (Eye Makeup Preparations), Powder
Date Published: 06/18/2014

Desc: Christian Eyebrow makeup black
Notes: 601 (a) adulteration;Aerococcus viridans, Alicyclobacillus acidoterrestris/ acidocaldarius/Brevibacillus choshinensis, B.cereus/thuringiensis/mycoides, B. pumilus, B. lentus, B. firmus, B. megaterium, B. vallismortis, B. subtilis/amyloliquefaciens/atrophaeus, enterobacter cloacae complex, Kocuria varians, Lysinibacillus sphaericus/Lysinicacillus fusiformis/Brevibacillus choshinensis, Moraxella lacunata/nonliquefaciens/osloensis, Paenibacillus alvei, Paenibacillus polymyxa, Pseudomonas stutzeri, Serratia liquefacien, Sphingomonas paucimobilis, S. aureus, S. epidermidis, S. homnis ssp. Hominis, S. saprophyticus, and Virgibacillus pantothenticus;5/23/2012

53 C H - 03 Eye Shadow (Eye Makeup Preparations), Powder
Date Published: 06/18/2014

Desc: Christian Eyebrow makeup Charcoal
Notes: 601 (a) adulteration;Aerococcus viridans, Alicyclobacillus acidoterrestris/ acidocaldarius/Brevibacillus choshinensis, B.cereus/thuringiensis/mycoides, B. pumilus, B. lentus, B. firmus, B. megaterium, B. vallismortis, B. subtilis/amyloliquefaciens/atrophaeus, enterobacter cloacae complex, Kocuria varians, Lysinibacillus sphaericus/Lysinicacillus fusiformis/Brevibacillus choshinensis, Moraxella lacunata/nonliquefaciens/osloensis, Paenibacillus alvei, Paenibacillus polymyxa, Pseudomonas stutzeri, Serratia liquefacien, Sphingomonas paucimobilis, S. aureus, S. epidermidis, S. homnis ssp. Hominis, S. saprophyticus, and Virgibacillus pantothenticus;5/23/2012

53 C H - 03 Eye Shadow (Eye Makeup Preparations), Powder
Date Published: 06/18/2014

Desc: Christian Eyebrow makeup Bronzed
Notes: 601 (a) adulteration;Aerococcus viridans, Alicyclobacillus acidoterrestris/ acidocaldarius/Brevibacillus choshinensis, B.cereus/thuringiensis/mycoides, B. pumilus, B. lentus, B. firmus, B. megaterium, B. vallismortis, B. subtilis/amyloliquefaciens/atrophaeus, enterobacter cloacae complex, Kocuria varians, Lysinibacillus sphaericus/Lysinicacillus fusiformis/Brevibacillus choshinensis, Moraxella lacunata/nonliquefaciens/osloensis, Paenibacillus alvei, Paenibacillus polymyxa, Pseudomonas stutzeri, Serratia liquefacien, Sphingomonas paucimobilis, S. aureus, S. epidermidis, S. homnis ssp. Hominis, S. saprophyticus, and Virgibacillus pantothenticus;5/23/2012

53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 06/18/2014

Desc: Eyebrow Make Up Kits
Notes: 601(a); Organisms recovered include Gram negative Pseudomonas oryzihabitans; Gram negative Pantoea spp; Gram positive rods; Gram negative Sphingomonas paucimobilis; Gram positive; Micrococcus spp; Oxidase positive; non-lactose fermenting and Gram positive spore forming bacillus; Pseudomonas Stutzeri; Sphingomonas paucimobilis; S. epidermidis; S. hominis; S. warneri; Serratia fonticola; Yeast and Mold. Published on 05/21/2012

Comercial Urania Sa De Cv
Date Published : 05/29/2012
Calle Saltillo No 119 , Col. Hipodromo, Cuauhtemoc , Ciudad De Mexico, Ciudad de Mexico MEXICO
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 05/29/2012

Desc: Moisturizing Cream
Notes: B.Cepacian

53 G - - 03 Foundations (Makeup Preparations, not for Eyes)
Date Published: 05/29/2012

Desc: Moisturizing Cream
Notes: B.Cepacian

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/29/2012

Desc: Moisturizing Cream
Notes: B.Cepacian

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/29/2012

Desc: Moisturizing Cream
Notes: B.Cepacian

Commercializadora Intergral Belleza Sa Cv
Date Published : 04/20/2012
Calle Ticoman No14 Tepeyac Insurgentes , Mexico City, MEXICO
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 04/20/2012

Desc: Mascara with Avocado oil
Notes: 601(a) Enterococcus faecium

Cosmetobellezas Natural S.A De C.V.
Date Published : 09/18/2009
Martin Luis Guzman 215 Col. Iztaccihuatl , Mexico D.F., MEXICO
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Mascara w/mamey seed oil;7/15/03
Notes: 601(a); gram negative rods

Dermatisse Cosmeticos S.A. De C.V.
Date Published : 03/14/2011
Av. San Jeronimo 506-A Col. San Jeronimo , Monterrey, MEXICO
53 C - - 02 Eyeliner (Eye Makeup Preparations)
Date Published: 03/14/2011

Desc: Eyeshadow Compact Dermatisse Brand
Notes: 601(a) Pseudomonas stutzeri; and shewanella Putrefaciens

53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 03/14/2011

Desc: Eyeshadow Compact Dermatisse Brand
Notes: 601(a) Pseudomonas stutzeri; and shewanella Putrefaciens

53 G - - 05 Lipstick (Makeup Preparations, not for Eyes)
Date Published: 03/14/2011

Desc: Eyeshadow Compact Dermatisse Brand
Notes: 601(a) Pseudomonas stutzeri; and shewanella Putrefaciens

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 03/14/2011

Desc: Eyeshadow Compact Dermatisse Brand
Notes: 601(a) Pseudomonas stutzeri; and shewanella Putrefaciens

Framesi Laboratorios, S.A. de C.V.
Date Published : 09/18/2009
Miguel Cruz Afdo. No. 10-B , Col. Flores Magon , Mexico, D.F. MEXICO
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Mascara with mamey seed oil; 9/4/03
Notes: 601(c); multiple micro contaminants & non-fermentative gram negative rods and gram positive rods with spores
Problems: ENTEROBACTER : CLOACAE;

53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Mascara w/avocado oil; 5/5/04
Notes: 601(a)
Problems: ENTEROBACTER : CLOACAE; PSEUDOMONAS : AERUGINOSA; LECLERCIA : ADECARBOXYLATA; KLEBSIELLA : PNEUMONIAE;

Industrializadora de Cacahuananche, S.A. de C.V.
Date Published : 10/12/2017
Calle Camino Arenero No. 20 , Pueblo San Juan de Ocotan , Zapopan, Jalisco MEXICO
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 10/12/2017

Desc: Shampoo Herbal Bear Oil Aceite de Oso
Notes: Problem(s); Pseudomonas Aeruginosa

Laboratorios Naturamex
Date Published : 09/18/2009
Calle Morelos Sur 899 , Col. Ventura Puente , Morelia, Michoacan MEXICO
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Avocado seed oil & mamey seed oil; 3/25/04
Notes: multiple micro contaminants including yeast/mold; gram positive rods; gram negative rods
Problems: STAPHYLOCOCCUS; CHRYSEOMONAS : LUTEOLA;

MEGAMIX
Date Published : 09/18/2009
Calle Antonio Alzate #71 Int. "A" Centro , Morelia, MEXICO
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 09/18/2009

Notes: Mascara; 5/10/05

53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations)
Date Published: 09/18/2009

Notes: Mascara;5/10/05

53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes)
Date Published: 03/30/2021

Desc: Mascara
Notes: 5/10/05

NATRA BAY SA DE CV
Date Published : 12/02/2013
Benito Juarez S/N Loc 2 Ent. Cjon , Col. CENTRO , Loreto, Baja California sur MEXICO
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/02/2013

Desc: Powdered Moringa Root
Notes: Charge -- Kleibseilla pneumonia

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/02/2013

Desc: Moringa Oil
Notes: Charge -- Yeast/mold

Probelco S.A. de D.V.
Date Published : 09/18/2009
Calle Biznaga No. 43 , Col. Las Palmas, Alvaro Obregon , Ciudad De Mexico, Ciudad de Mexico MEXICO
53 C - - 02 Eyeliner (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: 7/25/08
Notes: 601(a)
Problems: PSEUDOMONAS : PUTIDA;

Prosa Productos Naturales, S.A. de C.V.
Date Published : 09/18/2009
4a Cerrada Sur 57 174 , Mexico, DF MEXICO
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Mascara w/mamey seed oil;9/23/03
Notes: 601(a); gram positive and gram negative bacilli

REJUVENTUM, SA DE CV
Date Published : 12/17/2013
Calle Zaragoza No 1 , Col. Cuajimalpa, Cuajimalpa De Morelos , Ciudad De Mexico, Ciudad de Mexico MEXICO
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/17/2013

Desc: Hydrating Toner
Notes: CHARGE/CONTAMINANT -- 601(a); B. vallisomortis and E. gergoviae


MOROCCO


Lesieur Cristal
Date Published : 07/25/2011
1 Rue Caporal Branly , Casablanca, MOROCCO
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 07/25/2011

Desc: Soap 100% Clay
Notes: 601(a) Pseudomonas Stutzeri Cronobacter spp. Acinetobacter radiocresistens

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 03/30/2021

Desc: Soap 100% Clay
Notes: 601(a) Pseudomonas Stutzeri Cronobacter spp. Acinetobacter radiocresistens; 7/26/2011


PAKISTAN


M/S Taimoor Enterprises
Date Published : 09/18/2009
Flat # 28-29 2nd Floor P.m.c Khybar , Peshawar, PAKISTAN
53 C - - 02 Eyeliner (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Surma; eye liner; black powder; 1/23/07
Notes: 601(a); 601(c); a variety of microbes present; yeast and mold; Sphinomonas paucimoblis; M. haemolytica
Problems: STAPHYLOCOCCUS : AUREUS; ESCHERICHIA : COLI (TYPICAL);

Mm Laboratories
Date Published : 03/27/2015
Hafizabad Rd , Gujranwala, PAKISTAN
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/27/2015

Desc: Ashe Nu Face Cream
Notes: Problem(s); Mold Escherichia coli Gram-negative organisms; including opportunistic pathogens


PERU


PRODUCTOS JUMAM EIRL
Date Published : 09/18/2009
Jr. Pastaza 740 , LIMA, PE-LIM PERU
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/18/2009

Desc: mfr; Baba de Caracol Skin Cream; 8/3/07
Notes: 601(a)
Problems: PSEUDOMONAS : AERUGINOSA;

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/18/2009

Desc: mfr; Baba de Caracol Skin Cream; 8/3/07
Notes: 601(a)
Problems: PSEUDOMONAS : AERUGINOSA;

PRODUCTOS JUMAM EIRL
Date Published : 09/18/2009
Av Bolivia No 1014 , Brena, Lima PERU
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/01/2021

Desc: Baba de Caracol Skin Cream
Notes: shipper; 8/3/07; PSEUDOMONAS ; AERUGINOSA;


SINGAPORE


Lvmh Fragranc Cosmetics
Date Published : 04/11/2012
31 Jurong Port Rd , Jurong Logistics Hub, SINGAPORE
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 04/26/2021

Desc: Mascara (Fresh Supernova)
Notes: 601(a) Enterococcus casseliflavus; Microccus luteus and Staphylococcus lentus


SOUTH AFRICA


Bee Natural
Date Published : 09/14/2016
Plot 191 Canyon , Randvaal, SOUTH AFRICA
53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 09/14/2016

Desc: Living Clay Face Mask
Notes: CANDIDA PARAPSILOSIS; KLUYVERA INTERMEDIA; AEROMONAS SPP.
Problems: ENTEROBACTER : ASBURIAE; ENTEROBACTER : CLOACAE; ESCHERICHIA : COLI (TYPICAL); KLEBSIELLA : OXYTOCA; KLEBSIELLA : PNEUMONIAE SUBSP. PNEUMONIAE; KLUYVERA : CRYOCRESCENS; PSEUDOMONAS : PUTIDA;

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/14/2016

Desc: Living Clay Face Mask
Notes: CANDIDA PARAPSILOSIS; KLUYVERA INTERMEDIA; AEROMONAS SPP.
Problems: ENTEROBACTER : ASBURIAE; ENTEROBACTER : CLOACAE; ESCHERICHIA : COLI (TYPICAL); KLEBSIELLA : OXYTOCA; KLEBSIELLA : PNEUMONIAE SUBSP. PNEUMONIAE; KLUYVERA : CRYOCRESCENS; PSEUDOMONAS : PUTIDA;


TAIWAN


Chameleon Chao Ling Chemical Industrly Co
Date Published : 09/18/2009
21 Pu Ting Road , Hsinchu, TAIWAN
53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations)
Date Published: 03/29/2021

Desc: Cosmetics Plus Cosmetic Kits containing eye make-up
Notes: 601(a) ; Pseudomona;aeruginosa; 6/4/1997

Color Dreams
Date Published : 09/18/2009
No. 7, Lane 50, Nan Kung St , Yung Kang City, Tainan Hsien TAIWAN
53 G - - 01 Blushers (all Types) (Makeup Preparations, not for Eyes)
Date Published: 09/18/2009

Desc: Face Color Cosmetic; 7/14/06
Notes: 601(a)
Problems: STAPHYLOCOCCUS : AUREUS;

Lucky Seeds International
Date Published : 05/13/2010
2 Fl No. 1, Alley 3 Lane 13 , Kuh Luen Street , Taipei, TAIWAN
53 C - - -- Eye Makeup Prep
Date Published: 05/13/2010

Desc: Eye Makeup Kits
Notes: 601(a) S. epidermidis

Maxigen Biotech, Inc.
Date Published : 09/18/2009
Guishan District , No. 88 Keji 1st Rd.; Guishan Dist. , Taoyuan City, TAIWAN
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/18/2009

Notes: 601(a)
Problems: ACINETOBACTER : CALCOACETICUS; PSEUDOMONAS : MALTOPHILIA;

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/18/2009

Desc: Proto-Coll Anti-age Face Mask; 7/8/05
Notes: 601(a)
Problems: PSEUDOMONAS : MALTOPHILIA; ACINETOBACTER : CALCOACETICUS;

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 09/18/2009

Notes: 601(a)
Problems: PSEUDOMONAS : MALTOPHILIA; ACINETOBACTER : CALCOACETICUS;

Modish Collection International Co Ltd.
Date Published : 09/18/2009
No. 18 Lane 311 Cheng Chiang St , Tainan County, TAIWAN
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Mascara; 3/10/05
Notes: 601(a); spore forming gram pos rods; yeast
Problems: PSEUDOMONAS : NOT SPECIATED; STAPHYLOCOCCUS : AUREUS;

53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 03/29/2021

Desc: Mascara
Notes: 601 (a) Pseudomonas spp. S. aureus, Spore forming gram positive rods and yeast; 3/10/2005

Prince Chemical Ind Co Ltd
Date Published : 09/18/2009
No 12 Hsin Jen Road , Tainan, TAIWAN
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: 3/31/95
Notes: 601(a)
Problems: CITROBACTER : FREUNDII;

53 G - - 05 Lipstick (Makeup Preparations, not for Eyes)
Date Published: 09/18/2009

Desc: 3/31/95
Notes: 601(c)
Problems: STAPHYLOCOCCUS : SAPROPHYTICUS;

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc: Cosmetic Tote bags containing lipstick and/or eyeshadow; 5/16/95
Notes: 601(a); 601(c)
Problems: STAPHYLOCOCCUS : SAPROPHYTICUS; CITROBACTER : FREUNDII;

Ying Piao (Eagle) Industrial Co., Ltd.
Date Published : 01/08/2016
13 Zhong-Xin Rd , Puli, Nantou TAIWAN
53 C - - 02 Eyeliner (Eye Makeup Preparations)
Date Published: 04/26/2021

Desc: Nikka Notto Express Liquid Waterproof Eyeliner

53 C - - 99 Other Eye Makeup Preparations, N.E.C.
Date Published: 01/08/2016

Desc: Nikka Notto Express Liquid Waterproof Eyeliner
Problems: BURKHOLDERIA : CEPACIA;


THAILAND


S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED
Date Published : 04/05/2012
789/159 Moo 1, Nong Kho-Laemchabang Road , Si Racha, Chonburi THAILAND
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 04/05/2012

Desc: Body Shop Eye Colour 32 Chocolate
Notes: 601(a) Pseudomonas stutzeri, Acinetobacter Iwoffi, Micrococcus luteus and Moraxella nonliquifaciens

Siam Quality Industries Co Ltd
Date Published : 09/18/2009
Sainoi , 49 Moo 1, Bangbuatong-Ladbualuang Road , Sai Noi, Nonthaburi THAILAND
53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes)
Date Published: 09/18/2009

Desc: Crayon Face Paints; 5/16/06
Notes: 601(a); gram pos spore forming rods; yeast; mold
Problems: STAPHYLOCOCCUS : AUREUS;

53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes)
Date Published: 09/18/2009

Desc: Crayon Face Paint; 5/16/06
Notes: 601(a); gram pos spore forming rods; yeast; mold
Problems: STAPHYLOCOCCUS : AUREUS;

53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 09/18/2009

Desc: Crayon Face Paints; 5/16/06
Notes: 601(a); gram pos spore forming rods; yeast; mold
Problems: STAPHYLOCOCCUS : AUREUS;

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc: Crayon Face Paints; 5/16/06
Notes: 601(a); gram pos spore forming rods; yeast; mold
Problems: STAPHYLOCOCCUS : AUREUS;


TURKEY


GOODIE GIDA DIS TICARET LTD,STI
Date Published : 10/11/2022
Ahi Evran Osb Mah.Buyutimur Cad , No.3 Sincar , Ankara, TURKEY
53 A - - 04 Baby Wipes
Date Published: 10/11/2022

Desc: Baby Wipes
Notes: Gram Positive Rods 601(a) Contaminated with microorganisms

Kardesler Ucan Yaglar Sanayi Anonim Sirketi
Date Published : 10/11/2022
No:1 Inonu Mahallesi , Gebze, Kocaeli TURKEY
53 A - - 04 Baby Wipes
Date Published: 10/11/2022

Desc: Baby Wipes
Notes: Gram Positive Rods 601(a) Contaminated with microorganisms


UNITED KINGDOM


MEIYUME (UK) Ltd.
Date Published : 04/09/2010
Aintree Venue , Trowbridge, Wiltshire UNITED KINGDOM
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 04/09/2010

Desc: The Body Shop Define and Lengthen Mascara
Notes: 601(a); B. licheniformis, B. cereus

Neal's Yard Remedies (International) Ltd.
Date Published : 10/02/2013
Peacemarsh , Gillingham, Dorset UNITED KINGDOM
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 10/02/2013

Desc: Eye Shadow (Cocoa)
Notes: 601(a) B. species and B. liceniformis
Problems: ENTEROCOCCUS : CASSELIFLAVUS; BURKHOLDERIA : CEPACIA;

Neal's Yard Remedies (International) Ltd.
Date Published : 10/02/2013
Peacemarsh , Gillingham, Dorset UNITED KINGDOM
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 10/02/2013

Desc: Eye Shadow (Cocoa)
Notes: 601(a) B. species and B. liceniformis
Problems: ENTEROCOCCUS : CASSELIFLAVUS; BURKHOLDERIA : CEPACIA;