Import Alert 55-05

(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 # 55-05
Published Date: 08/23/2017
Type: DWPE

Import Alert Name:

DETENTION WITHOUT PHYSICAL EXAMINATION OF FINISHED DOSAGE DRUG PRODUCTS, ACTIVE PHARMACEUTICAL INGREDIENTS AND INACTIVE INGREDIENTS FOR POTENTIALLY HAZARDOUS MICROBIOLOGICAL CONTAMINATION

Reason for Alert:

Due to similar issues, the information in IA #55-04 is being incorporated into this alert and will henceforth be discontinued.



FDA collects and analyzes samples of finished dosage products, active pharmaceutical ingredients and inactive ingredients considered at risk for potentially hazardous microbial contamination that pose a health risk. Detention without physical examination may be appropriate when sample results reveal a potential health risk.

Guidance:

Districts may detain, without physical examination, the specified

products from the firms listed in the Red List of this Import Alert.



Districts should recommend detention without physical examination under this import alert when analytical results reveal the presence of potentially hazardous microbial contamination for pharmaceutical use. Forward background information, including analytical worksheets, product labeling and entry documents, to the Division of Import Operations (DIO). DIO will coordinate with CDER for concurrence.



In order for a firm to be removed from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. This may include a letter detailing its corrective actions, accompanied by documentation.



For guidance on removal from detention without physical examination,

refer to FDAs Regulatory Procedures Manual, Chapter 9, "Detention

Without Physical Examination (DWPE)."



If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:



Food and Drug Administration

Division of Import Operations

12420 Parklawn Drive, ELEM-3109

Rockville, MD 20857



Or via email: Importalerts2@fda.hhs.gov



For questions or issues involving import operations, contact the Division of Import Operations at (301) 796-0356.



For questions or issues concerning science, science policy, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at (301) 796-6600.

Product Description:

CDER regulated finished dosage form drug products, active pharmaceutical ingredients, and inactive ingredients

Charge:

The article is subject to refusal of admission pursuant to section 801(a)(3) of the FFD&CA in that the article contains potentially hazardous, or otherwise objectionable in light of intended use, microbial adulteration and therefore consists in part of a filthy substance. [Adulteration, Section 501(a)(1)].

OASIS CHARGE CODE: FILTH



AND/OR



The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions

OASIS CHARGE CODE: MFR INSAN



AND/OR



The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health [Adulteration, Section 501(a)(2)(A)].

OASIS CHARGE CODE: INSANITARY



AND/OR



The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or holding of the article do not appear to conform to or are not operated or administered in conformity with current

good manufacturing practices. [Adulteration, Section 501(a)(2)(B)].

OASIS CHARGE CODE: DRUG GMPs



PROBLEM: Adulteration

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


CANADA


Delta Pharma Inc.
Date Published : 05/22/2013
1655 Rte Transcanadienne , Dorval, Quebec CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/22/2013

Desc:Face Values for Baby Healing Ointment


INDIA


Contacare Ophthalmics & Diagnostics
Date Published : 08/23/2017
310b Village Sim , Block No , Dabhasa, Gujarat INDIA
55 R P - 14 Hydroxypropyl Methylcellulose (Pharmaceutic Necessity - Suspending Agent), Pharma Necess
Date Published: 08/23/2017

Desc:Hydroxypropyl Methyl Cellulose
Notes:DWPE applies to all aseptically processed drugs manufactured or shipped by Contacare Ophthalmics & Diagnostics.

55 R P - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Pharma Necess
Date Published: 08/23/2017

Desc:Sodium Chloride
Notes:DWPE applies to all aseptically processed drugs manufactured or shipped by Contacare Ophthalmics & Diagnostics.

63 X C P 69 Iopydol (Diagnostic Aid) (Drugs), Human - Rx/Single Ingredient, Small Volume Parenteral <100ml
Date Published: 08/23/2017

Desc:Lopydol
Notes:DWPE applies to all aseptically processed drugs manufactured or shipped by Contacare Ophthalmics & Diagnostics.

63 X - - 12 Fluorescein Sodium (Diagnostic Aid) (Drugs)
Date Published: 08/23/2017

Desc:Fluorescein Sodium
Notes:DWPE applies to all aseptically processed drugs manufactured or shipped by Contacare Ophthalmics & Diagnostics.

63 X - - 99 Diagostic Aid (Drugs) N.E.C.
Date Published: 08/23/2017

Desc:Sodium Chloride
Notes:DWPE applies to all aseptically processed drugs manufactured or shipped by Contacare Ophthalmics & Diagnostics.

65 R A K 19 Sodium Chloride (Replenisher), Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 08/23/2017

Desc:Sodium Chloride
Notes:DWPE applies to all aseptically processed drugs manufactured or shipped by Contacare Ophthalmics & Diagnostics.


KOREA, REPUBLIC OF (SOUTH)


Neo Vision Co., Ltd.
Date Published : 12/13/2016
93 Jeungsin-ro , Iceon-si, Gyeonggi-do KOREA, REPUBLIC OF (SOUTH)
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/13/2016

Notes:All drugs and drug products

56 - - - -- Antibiotics (Human/Animal)
Date Published: 12/13/2016

Notes:All drugs and drug products

60 - - - -- Human and Animal Drugs
Date Published: 12/13/2016

Notes:All drugs and drug products

61 - - - -- Human and Animal Drugs
Date Published: 12/13/2016

Notes:All drugs and drug products

62 - - - -- Human and Animal Drugs
Date Published: 12/13/2016

Notes:All drugs and drug products

63 - - - -- Human and Animal Drugs
Date Published: 12/13/2016

Notes:All drugs and drug products

64 - - - -- Human and Animal Drugs
Date Published: 12/13/2016

Notes:All drugs and drug products

65 - - - -- Human and Animal Drugs
Date Published: 12/13/2016

Notes:All drugs and drug products

66 - - - -- Human and Animal Drugs
Date Published: 12/13/2016

Notes:All drugs and drug products


MEXICO


Brady Mexico S De RL de CV
Date Published : 08/26/2016
Guerrero Negro , Tijuana, Bc MEXICO
55 R - - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent)
Date Published: 08/26/2016

Desc:Eyesaline Eyewash
Notes:                                                                                                                                                                                                                               

55 R - - 56 Ethyl Oleate (Pharmaceutic Necessity - Vehicle)
Date Published: 08/26/2016

Desc:Eyesaline Eyewash
Notes:                                                                                                                                                                                                                               

65 F - - 06 Water, Purified (Eyewash)
Date Published: 08/26/2016

Desc:Eyesaline Eyewash
Notes:                                                                                                                                                                                                                               

65 R - - 12 Potassic Saline (Injection) (Replenisher)
Date Published: 08/26/2016

Desc:Eyesaline Eyewash
Notes:                                                                                                                                                                                                                               


UNITED STATES


Sperian Eye & Face Protection, Inc
Date Published : 08/26/2016
825 E Business Highway 151 , Platteville, WI 53818-3763 UNITED STATES
55 R - - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent)
Date Published: 08/26/2016

Desc:Eyesaline Eyewash

55 R - - 56 Ethyl Oleate (Pharmaceutic Necessity - Vehicle)
Date Published: 08/26/2016

Desc:Eyesaline Eyewash

65 F - - 06 Water, Purified (Eyewash)
Date Published: 08/26/2016

Desc:Eyesaline Eyewash

65 R - - 12 Potassic Saline (Injection) (Replenisher)
Date Published: 08/26/2016

Desc:Eyesaline Eyewash