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U.S. Department of Health and Human Services

Import Alert 68-02
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(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 # 68-02
Published Date: 12/10/2012
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Of Veterinary Drugs From Firms That Have Not Met Drug GMPs"

Reason for Alert:
FDA performs foreign inspections of veterinary pharmaceutical manufacturers. FDA may detain products from inspected firms if inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's).

When, and if, FDA confirms that the firm is in compliance with GMP [corrections have been made], the respective firm's pharmaceutical products will be removed from Detention Without Physical Examination.

Guidance:
Districts may detain the specified veterinary pharmaceutical products from the firms identified in the attachment to this alert.

Product Description:
Veterinary drugs

Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that the methods used in, or the facilities or controls used for, its manufacturing, processing, packing, or holding do not 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

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


BAHAMAS
Howard Medical International
Date Published : 12/10/2012

Trinity Place Annex , Nassau, BAHAMAS
86 L - - ZP Aid, Surgical, Viscoelastic
Date Published: 12/10/2012

Desc:Perfluorodecaline for vet use

CHINA
Guangdong Pharmaceutical Factory #1
Date Published : 09/10/2009

91 Fangcun Dadao , Guangzhou, CHINA
67 B - - -- Category II
Date Published: 09/10/2009

Notes:Active Pharmaceutical Ingredients

MEXICO
Sierra Pharmaceuticals Inc Sa De Cv
Date Published : 09/10/2009

Circuito De Las Misiones Nte. #172 , Mod. L Parque Ind. Las Californas , Mexicali, Baja California MEXICO
68 - - K -- Animal Devices and Diagnostic Products
Date Published: 09/10/2009

Notes:DWPE date - 7/24/1998
68 - - N -- Animal Devices and Diagnostic Products
Date Published: 09/10/2009

Notes:DWPE date - 7/24/1998
68 - - P -- Animal Devices and Diagnostic Products
Date Published: 09/10/2009

Notes:DWPE date - 7/24/1998

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