Import Alert 85-02
(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 # 85-02
Published Date: 03/21/2023
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Condoms"
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 03/21/2023 updates the subtype of the alert to firm alert, reason for alert and guidance section including agency contacts and charge code language. Changes to the import alert are bracketed by asterisks (***).
Reason for Alert:
***Consumers rely on condoms for protection from HIV (AIDS) and other sexually transmitted diseases (STDs). Defective condoms present a potential hazard to health. Therefore, continuous monitoring of these devices is needed. ***
Reason for Alert:
***Consumers rely on condoms for protection from HIV (AIDS) and other sexually transmitted diseases (STDs). Defective condoms present a potential hazard to health. Therefore, continuous monitoring of these devices is needed. ***
Guidance:
***Divisions may detain, without physical examination, all shipments of condoms from the firms identified on the Red List of this import alert. ***
NOTE:
Because the presence of defects in condoms represents a potential hazard to health, only one (1) violative sample is needed to submit a recommendation for detention without physical examination to the Division of Import Operations (DIO). DIO has direct reference authority for detention without physical examination of condoms. Violative condoms are subject to RPM Chapter 9-8-8, Detention Without Physical Examination, subchapter "Recommendations Based on One Violative Sample."
The following procedure has been developed to address those firms who are found to repeatedly ship violative condoms to the U.S. (recidivist firms.)
***Level 1 Detention (INDICATED by a "Level 1" detention designation in the "notes" portion of the firm listing on THE RED LIST)***
When a division encounters a shipment of condoms which is found violative for defects by FDA analysis, the shipment should be detained and a recommendation for detention without physical examination should be forwarded to DIO.
***If the recommendation meets current guidance, the firm will be placed on the Red List, with a "note" to designate that firm is on Level 1 detention and subsequent condom shipments from that firm may be detained without physical examination. The importer may obtain release of subsequently detained shipments of condoms by presenting evidence that the individual shipments are not adulterated, such as sample analyses performed by an independent testing laboratory in the U.S., following the sampling plan and test method contained in FDA guidance.***
In order for the responsible firm's name to be removed from the Red List, documentation should be provided with sufficient evidence that condoms are not adulterated (for example, a minimum of five consecutive non violative shipments analyzed as described in the preceding paragraph may be considered adequate evidence for firms to be removed from Level 1 detention).
Level 2 Detention (Recidivist firms which are currently on Level 1 detention, or which have been removed from Level 1 detention).
If a firm, while on Level 1 detention, has a sample analyzed by an independent testing laboratory found violative for defects, the district should notify DIO and submit supporting documentation. ***DIO will place the firm on Level 2 detention and identify the firm on the Red List with designation of "Level 2" detention in the "Notes" section of the firm listing.***
Similarly, if a firm that has been removed from Level 1 detention has a sample analyzed by FDA and found violative for defects within 24 months from the date they were removed from Level 1 detention, the division should notify DIO and submit supporting documentation. ***DIO will verify the firm was listed under Level 1 detention during the past 24 months and if confirmed will place the firm on Level 2 detention and identify the firm on the Red List with the designation of "Level 2" detention in the "Notes" section of the firm listing.***
DIO will notify CDRH of this action. CDRH will notify the foreign firm in writing of FDA's concerns about potential deficiencies in the manufacturing practices and process controls which may be affecting the quality of the condoms shipped to the U.S. A copy of the Quality Systems Regulation will be provided with the letter for their information.
Once a firm is placed on Level 2 detention, FDA may need greater assurance that the condoms are not adulterated before removing the firm from detention without physical examination status. For example, a minimum of 10 consecutive non violative shipments, analyzed by an independent testing laboratory for defects, may be considered adequate evidence that the firm is shipping condoms to the U.S. which are not adulterated. Other types of evidence to remove the appearance of a violation will be evaluated by CDRH on a case-by-case basis.
Level 3 Detention (Recidivist firms which are currently on Level 2 detention, or which have been removed from Level 2 detention).
If a firm, while on Level 2 detention, has another sample analyzed and found violative for defects by an independent testing laboratory, the district should notify DIO and submit supporting documentation.
Similarly, if a firm who was removed from Level 2 detention has another sample analyzed by FDA and has been found violative for defects within 24 months from the date they were removed from Level 1 detention or from the date they were placed on Level 2 detention, DIO will bring these instances to the attention of CDRH. ***DIO will verify the firm was listed under Level 2 detention during the past 24 months, and if confirmed, will place the firm on the Red List with a designation of "Level 3" detention in the "Notes" section of the firm listing.***
Non violative analyses may not be sufficient to remove the appearance of a violation for firms designated on Level 3 detention on the Red List. Firms will remain on Level 3 detention until evidence is provided to CDRH which demonstrates that the condoms are being manufactured in accordance with the Quality System Regulation (for example, an acceptable FDA inspection or a written certification from the firm together with the results of an independent audit performed by a qualified third party).
Once a foreign firm satisfactorily demonstrates that the apparent Quality System Regulation deviations have been corrected, the firm will be removed from ***Level 3 detention*** and placed on Level 1 detention on the Red List for individual shipment analysis to confirm their condoms do not contain defects until they provide adequate evidence to be removed from Level 1 detention (see above).
*** Release of Article Subject to DWPE Under this Import Alert:
In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide FDA documentation to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. Testimony suggestions are provided above in guidance for recidivist firms.
Removal from Detention Without Physical Examination:
In order to remove a firm's product from the Red List, if the Agency is unable to conduct an inspection of the facility to determine if appropriate action(s) have been initiated to identify and correct potential deficiencies, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is to ensure the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)."
If a firm, and/or a representative thereof would like to request removal from detention without physical examination 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 (DIO)
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email: Importalerts2@fda.hhs.gov
DIO will coordinate the evaluation of a request for removal from detention without physical examination with CDRH Office of Regulatory Programs.
Questions or issues involving import operations should be addressed to ORA/DIO (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.
For questions concerning the Compliance Policy Guides (CPG), condom labeling, or other compliance policy questions, contact CDRH, Office of Regulatory Programs, Division of Regulatory Programs 2- Establishment Support, via an email at the CDRH Import Mailbox(cdrhimport@fda.hhs.gov)
***
NOTE:
Because the presence of defects in condoms represents a potential hazard to health, only one (1) violative sample is needed to submit a recommendation for detention without physical examination to the Division of Import Operations (DIO). DIO has direct reference authority for detention without physical examination of condoms. Violative condoms are subject to RPM Chapter 9-8-8, Detention Without Physical Examination, subchapter "Recommendations Based on One Violative Sample."
The following procedure has been developed to address those firms who are found to repeatedly ship violative condoms to the U.S. (recidivist firms.)
***Level 1 Detention (INDICATED by a "Level 1" detention designation in the "notes" portion of the firm listing on THE RED LIST)***
When a division encounters a shipment of condoms which is found violative for defects by FDA analysis, the shipment should be detained and a recommendation for detention without physical examination should be forwarded to DIO.
***If the recommendation meets current guidance, the firm will be placed on the Red List, with a "note" to designate that firm is on Level 1 detention and subsequent condom shipments from that firm may be detained without physical examination. The importer may obtain release of subsequently detained shipments of condoms by presenting evidence that the individual shipments are not adulterated, such as sample analyses performed by an independent testing laboratory in the U.S., following the sampling plan and test method contained in FDA guidance.***
In order for the responsible firm's name to be removed from the Red List, documentation should be provided with sufficient evidence that condoms are not adulterated (for example, a minimum of five consecutive non violative shipments analyzed as described in the preceding paragraph may be considered adequate evidence for firms to be removed from Level 1 detention).
Level 2 Detention (Recidivist firms which are currently on Level 1 detention, or which have been removed from Level 1 detention).
If a firm, while on Level 1 detention, has a sample analyzed by an independent testing laboratory found violative for defects, the district should notify DIO and submit supporting documentation. ***DIO will place the firm on Level 2 detention and identify the firm on the Red List with designation of "Level 2" detention in the "Notes" section of the firm listing.***
Similarly, if a firm that has been removed from Level 1 detention has a sample analyzed by FDA and found violative for defects within 24 months from the date they were removed from Level 1 detention, the division should notify DIO and submit supporting documentation. ***DIO will verify the firm was listed under Level 1 detention during the past 24 months and if confirmed will place the firm on Level 2 detention and identify the firm on the Red List with the designation of "Level 2" detention in the "Notes" section of the firm listing.***
DIO will notify CDRH of this action. CDRH will notify the foreign firm in writing of FDA's concerns about potential deficiencies in the manufacturing practices and process controls which may be affecting the quality of the condoms shipped to the U.S. A copy of the Quality Systems Regulation will be provided with the letter for their information.
Once a firm is placed on Level 2 detention, FDA may need greater assurance that the condoms are not adulterated before removing the firm from detention without physical examination status. For example, a minimum of 10 consecutive non violative shipments, analyzed by an independent testing laboratory for defects, may be considered adequate evidence that the firm is shipping condoms to the U.S. which are not adulterated. Other types of evidence to remove the appearance of a violation will be evaluated by CDRH on a case-by-case basis.
Level 3 Detention (Recidivist firms which are currently on Level 2 detention, or which have been removed from Level 2 detention).
If a firm, while on Level 2 detention, has another sample analyzed and found violative for defects by an independent testing laboratory, the district should notify DIO and submit supporting documentation.
Similarly, if a firm who was removed from Level 2 detention has another sample analyzed by FDA and has been found violative for defects within 24 months from the date they were removed from Level 1 detention or from the date they were placed on Level 2 detention, DIO will bring these instances to the attention of CDRH. ***DIO will verify the firm was listed under Level 2 detention during the past 24 months, and if confirmed, will place the firm on the Red List with a designation of "Level 3" detention in the "Notes" section of the firm listing.***
Non violative analyses may not be sufficient to remove the appearance of a violation for firms designated on Level 3 detention on the Red List. Firms will remain on Level 3 detention until evidence is provided to CDRH which demonstrates that the condoms are being manufactured in accordance with the Quality System Regulation (for example, an acceptable FDA inspection or a written certification from the firm together with the results of an independent audit performed by a qualified third party).
Once a foreign firm satisfactorily demonstrates that the apparent Quality System Regulation deviations have been corrected, the firm will be removed from ***Level 3 detention*** and placed on Level 1 detention on the Red List for individual shipment analysis to confirm their condoms do not contain defects until they provide adequate evidence to be removed from Level 1 detention (see above).
*** Release of Article Subject to DWPE Under this Import Alert:
In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide FDA documentation to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. Testimony suggestions are provided above in guidance for recidivist firms.
Removal from Detention Without Physical Examination:
In order to remove a firm's product from the Red List, if the Agency is unable to conduct an inspection of the facility to determine if appropriate action(s) have been initiated to identify and correct potential deficiencies, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is to ensure the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)."
If a firm, and/or a representative thereof would like to request removal from detention without physical examination 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 (DIO)
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email: Importalerts2@fda.hhs.gov
DIO will coordinate the evaluation of a request for removal from detention without physical examination with CDRH Office of Regulatory Programs.
Questions or issues involving import operations should be addressed to ORA/DIO (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.
For questions concerning the Compliance Policy Guides (CPG), condom labeling, or other compliance policy questions, contact CDRH, Office of Regulatory Programs, Division of Regulatory Programs 2- Establishment Support, via an email at the CDRH Import Mailbox(cdrhimport@fda.hhs.gov)
***
Product Description:
Condoms made from latex or synthetic material
NOTE: This import alert does not apply to natural membrane condoms or to female condoms.
NOTE: This import alert does not apply to natural membrane condoms or to female condoms.
Charge:
For lots that exceed an Acceptable Quality Level (AQL) of 0.4%:
***The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes. [Adulteration, 501(c)]***
OASIS charge code - HOLES
If the condoms are labeled for the prevention of disease, also charge:
***The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading. [Misbranding, section 502(a)]***
OASIS charge code - FALSE
***When FDA has documented repeated violations, and the firm is listed as Level 3 detention on the Red List of the import alert per the Recidivist Policy described above, future shipments may be detained charging the following:
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.[Adulteration, section 501(h)]***
OASIS charge code - DEVICE GMP
***The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes. [Adulteration, 501(c)]***
OASIS charge code - HOLES
If the condoms are labeled for the prevention of disease, also charge:
***The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading. [Misbranding, section 502(a)]***
OASIS charge code - FALSE
***When FDA has documented repeated violations, and the firm is listed as Level 3 detention on the Red List of the import alert per the Recidivist Policy described above, future shipments may be detained charging the following:
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.[Adulteration, section 501(h)]***
OASIS charge code - DEVICE GMP
Countries
MULTIPLE COUNTRIES
-
(85 H - - IS) CondomDesc: Condom
-
(85 L - - TZ) Condom With Nonoxynol-9Desc: Condom with Nonoxynol-9
-
(85 M - - OL) Condom, Non-LatexDesc: Condom Non-Latex
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
BANGLADESH
Social Marketing Company
Date Published : 09/16/2009
House No 105 Road No 9A Dhanmondl , GPO Box 690
, Dhaka,
BANGLADESH
85 H - - IS Condom
Date Published: 09/16/2009
Notes: firm is on Level 1 Detention Latex Condoms
85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/16/2009
Notes: Latex Condoms
CHILE
SAGRA LABORATORY
Date Published : 09/16/2009
IGNACIO VALDIVIESO 2451
, SAN JOAQUIN,
CHILE
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Latex Condoms; Firm si on Level 1 Detention
85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/16/2009
Notes: Latex Condoms; Firm si on Level 1 Detention
CHINA
Guilin Zizhu Latex Co., Ltd
Date Published : 09/16/2009
NO. 6 Wushanlu
, Guilin City,
Guangxizhuangzuzizhiqu CHINA
85 H - - IS Condom
Date Published: 09/16/2009
Notes: All types of Condoms; Firm is on Level 1 Detention
85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/16/2009
Notes: All types of Condoms; Firm is on Level 1 Detention
85 M - - OL Condom, Non-Latex
Date Published: 09/16/2009
Notes: All types of Condoms; Firm is on Level 1 Detention
Lestitch Co Ltd
Date Published : 08/31/2010
212 Zhaojiabang Road
, Shanghai,
CHINA
85 H - - IS Condom
Date Published: 08/31/2010
Desc: Latex Condoms
Notes: Level 1
85 L - - TZ Condom With Nonoxynol-9
Date Published: 08/31/2010
Desc: Latex Condoms
Notes: Level 1
85 M - - OL Condom, Non-Latex
Date Published: 08/31/2010
Desc: Latex Condoms
Notes: Level 1
Pleasure Chest Group Company Ltd
Date Published : 09/13/2011
Add F6 No.777 North Chouzhou Rd
, Zhejiang,
CHINA
85 H - - IS Condom
Date Published: 09/13/2011
Desc: Condoms
85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/13/2011
Desc: Condoms
85 M - - OL Condom, Non-Latex
Date Published: 09/13/2011
Desc: Condoms
SHANDONG DAHUI LATEX SCIENCE AND TECHNOLOGY CO., LTD
Date Published : 09/26/2011
Tangkou Industry Garden
, Jining,
CHINA
85 H - - IS Condom
Date Published: 09/26/2011
Desc: Condoms
85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/26/2011
Desc: Condoms
85 M - - OL Condom, Non-Latex
Date Published: 09/26/2011
Desc: Condoms
Tianjin Medicines & Health Products Import & Export Corp.
Date Published : 09/16/2009
Hai Tai Information Square, Hi-Tech Indu , Building C 5th Floor; NO. 8 Huatiandao
, Tianjin,
Tianjin CHINA
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Partners Brand Blue Spermicidally Lubricated w/Nonoxynol-9; extra
strength condom; Partners brankd Yellow Spermicidally Lubricated
w/Nonoxyol-9 condoms. Firm is on Level 1 Detention
GERMANY
Don Geschenkartikel-Neuheiten Dolores Obidos-Naumann
Date Published : 09/16/2009
Am Stadtbruch 14 , P O Box 1170
, Volkmarsen,
GERMANY
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Firm is on Detention level one. All condoms
HONG KONG SAR
Anna Mfgr LTD
Date Published : 09/16/2009
unknown
, Hong Kong,
HONG KONG SAR
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Firm is on Detention level one. All condoms
HUNGARY
Industat Budapest KFT
Date Published : 09/16/2009
unknown
, Budapest,
HUNGARY
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Firm is on Detention level one. All condoms
INDIA
HEALTH CARE LATEX LTD.
Date Published : 09/16/2009
A-33/A SECTOR-8
, Noida (U.P.),
INDIA
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Firm is on Detention level one. Latex Condoms
85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/16/2009
Notes: Firm is on Detention level one. Latex Condoms
Hindustan Latex, Limited
Date Published : 09/16/2009
Latex Bhavan Poojapura
, Thiru Vanath Puram,
INDIA
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Firm is on Detention level one. Condoms(Bull Dog Brand)
M/S Suruchi International
Date Published : 09/16/2009
207 Sector 7a Fardabad 121001
, Haryana,
INDIA
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Firm is on Detention level one. Latex Condoms
85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/16/2009
Notes: Firm is on Detention level one. Latex Condoms
85 M - - OL Condom, Non-Latex
Date Published: 09/16/2009
Notes: Firm is on Detention level one. Latex Condoms
KOREA (THE REPUBLIC OF)
BioGenetics Co. Ltd.
Date Published : 03/24/2016
473-3, Gwangjiang-Ro, Jeungpyeong-Eup , Jeungpyeong-Gun
, Chungbuk,
KOREA (THE REPUBLIC OF)
85 H - - IS Condom
Date Published: 03/24/2016
Desc: Condoms
Notes: Level 2
85 L - - TZ Condom With Nonoxynol-9
Date Published: 03/24/2016
Desc: Condoms
Notes: Level 2
85 M - - OL Condom, Non-Latex
Date Published: 03/24/2016
Desc: Condoms
Notes: Level 2
Greenmate Corporation
Date Published : 09/16/2009
1443-15 Seocho-Dong , Seocho-Ku
, Seoul,
KOREA (THE REPUBLIC OF)
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Firm is on Detention level one. Latex Condoms
Orient Medical Supply Co Ltd (office)
Date Published : 09/16/2009
159 Sam Sung Dong , Room 3403 Korean World Trade Center
, Seoul,
KOREA (THE REPUBLIC OF)
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Firms on detention level 1
Orient Medical Supply Co., Ltd.
Date Published : 09/16/2009
258-1, Youngwon-Ree, Sungnan- , Myun, Chunwon-Gun
, Choongchung,
Nam-Do KOREA (THE REPUBLIC OF)
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Firm on detention level 1
Shinheng Corporation
Date Published : 09/16/2009
Rm 1003 Daejun Bldg , 1318-4 Socho-Dong
, Socho-Gu,
Seoul KOREA (THE REPUBLIC OF)
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Firm on detention level1
Sol Medical Supply Co. Ltd.
Date Published : 09/16/2009
Unknown Street
, Seoul,
KOREA (THE REPUBLIC OF)
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Firm on detention level1
Unidus Corporation
Date Published : 03/24/2016
Seokyung Bldg., 51 Bang-I Dong , Songpa-Ku
, Seoul,
KOREA (THE REPUBLIC OF)
85 H - - IS Condom
Date Published: 03/24/2016
Desc: Condoms
Notes: Level 2
85 L - - TZ Condom With Nonoxynol-9
Date Published: 03/24/2016
Desc: Condoms
Notes: Level 2
85 M - - OL Condom, Non-Latex
Date Published: 03/24/2016
Desc: Condoms
Notes: Level 2
MALAYSIA
LS Rubber Sdn. Bhd.
Date Published : 09/16/2009
Plo 22 (Phase 1) , Jalan Perindustrian Senai 3
, Senai,
Johor MALAYSIA
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Firm on detention level 1; Condoms flavored
THAILAND
Royal Industries Thailand Co Ltd
Date Published : 09/16/2009
218/5-6 Soi Rama 1 Road , Box 1347
, Bangkok,
THAILAND
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Firm on detention level1
S L D International Co Ltd aka Ken Nona
Date Published : 09/16/2009
16 Asoke Rd Sukhumvit SOI 21
, Bangkok,
Prakanong THAILAND
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Firm on detention level1
UNITED KINGDOM
PHS Limited
Date Published : 09/16/2009
Claymore Tame Valley Industrial Estate
, Tamworth,
UNITED KINGDOM
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Firms is on detention level 1; condoms with nonoxynol-9