Unapproved Drugs: Firm Actions

Since publication of the CPG, the Agency has taken enforcement actions against a number of firms with significant violations of current good manufacturing practice (CGMPs) or adverse event reporting requirements that also make unapproved drugs.

• Abraxis Bioscience, Inc.
• Actavis Totowa, LLC
• Amerifit Brands, Inc.
• ANIP Acquisition Company
• Bryant Ranch Prepac
• Claris Lifesciences, Limited
• Concord Laboratories, Inc.
• Contract Pharmacal Corporation
• C. R. Canfield Co., Inc.
• Deltex Pharmaceuticals, Inc.
• Deston Therapeutics
• Elge, Inc.
• G & W Laboratories, Inc.
• Hi-Tech Pharmacal Co., Inc.
• Hill Dermaceuticals, Inc.
• IriSys, Inc.
• Keystone Pharmaceuticals
• KV Pharmaceutical Company
• McGuff Pharmaceuticals, Inc.
• Midland Pharmaceutical LLC
• Neil Laboratories, Inc.
• Neilgen Pharmaceuticals, Inc.
• Nexgen Pharma, Inc.
• Ohm Laboratories, Inc.
• PharmaFab, Inc.
• Pharmakon Laboratory, Inc.
• Pharma Pac, LLC
• PrimaPharm, Inc.
• Provident Pharmaceuticals, LLC
• River's Edge Pharmaceuticals, LLC
• RGH & Company Inc., dba Vital Nutrients
• Scientific Laboratories, Inc.
• Sheffield Laboratories, Division of Faria Limited LLC
• Sunrise Pharmaceutical, Inc.
• Syntho Pharmaceuticals, Inc. and Intermax Pharmaceuticals, Inc.
• Time-Cap Laboratories, Inc.
• Tri-Med Laboratories, Inc.
• Vintage Pharmaceuticals, LLC
• Vita-Erb, Ltd.

Abraxis Bioscience, Inc.

• Warning Letter (PDF - 557KB) (Issued December 18, 2006)

Actavis Totowa, LLC

• FDA News: FDA Awaits Court's Entry of A Permanent Injunction Against Actavis Totowa, LLC (issued January 9, 2009)
• Warning Letter (Issued February 26, 2007)
• Warning Letter (Issued August 15, 2006)
• Consent Decree of Permanent Injunction (PDF - 501KB) (January 22, 2009)

Amerifit Brands, Inc.

• Warning Letter (Issued November 7, 2007)

ANIP Acquisition Company

• Warning Letter (Issued August 21, 2009)

Bryant Ranch Prepac

• Warning Letter (Issued April 8, 2010)

Claris Lifesciences Limited

• Warning Letter (Issued November 1, 2010)

Concord Laboratories, Inc.

• Warning Letter (Issued July 11, 2006)

Contract Pharmacal Corporation

• Warning Letter (Issued October 14, 2010)

C. R. Canfield Co., Inc.

• FDA News: Permanent Injunction of Dental Products Manufacturer Furthers FDA Efforts Against Marketed Unapproved Drugs (Issued October 6, 2006)
• Warning Letter (Issued September 24, 2004)
• Consent Decree of Permanent Injunction (PDF - 35KB) (September 18, 2006)
• FDA Complaint for Permanent Injunction (PDF - 90KB) (September 15, 2006)

Deltex Pharmaceuticals Inc.

• Warning Letter (Issued October 21, 2008)
• Consent Decree of Permanent Injunction (PDF - 270KB) (December 23, 2010)

Deston Therapeutics

• FDA News:  U.S. Marshals seize Auralgan Otic Solution (February 16, 2011)
   

Elge, Inc.

• Warning Letter (Issued May 8, 2008)

G & W Laboratories, Inc.

• Warning Letter (Issued July 24, 2008)

Hi-Tech Pharmacal Co., Inc.

• Warning Letter (Issued June 28, 2010)

Hill Dermaceuticals, Inc.

• Warning Letter (Issued August 18, 2009)

IriSys, Inc.

• Warning Letter (Issued August 23, 2010)

Keystone Pharmaceuticals

• FDA News:  Federal Government Seizes Cyanide Antidote Kits from California Company (July 22, 2010)

KV Pharmaceutical Company

• FDA News: Federal Agents Seize more than $24 Million in Unapproved New Drugs (Issued July 30, 2008)
• Federal Register Notice (May 29, 2007)
• Consent Decree of Permanent Injunction (PDF - 461KB) (March, 2009)

McGuff Pharmaceuticals, Inc.

• Warning Letter (Issued December 28, 2010)

Midland Pharmaceutical LLC

• Warning Letter (Issued March 3, 2008)

Neil Laboratories, Inc.

• Warning Letter (Issued May 31, 2006)

Neilgen Pharmaceuticals, Inc.

• FDA News: FDA Obtains Permanent Injunction Barring Two Companies from Manufacturing and Distributing Unapproved Drugs (Issued April 10, 2009)
• Consent Decree of Permanent Injunction (PDF - 230KB) (April 9, 2009)

Nexgen Pharma, Inc.

• Warning Letter (Issued September 27, 2010)

Ohm Laboratories, Inc.

• Warning Letter (Issued December 21, 2009)

PharmaFab Inc.

• FDA News: Manufacturer of Unapproved and Adulterated Drugs Agrees to Stop Illegal Practices (Issued April 25, 2007)
• Consent Decree of Permanent Injunction (PDF - 1.4MB) (April 24, 2007)
• FDA Complaint for Permanent Injunction (PDF - 1.2MB) (April 20, 2007)
• Warning Letter (Issued October 11, 2002)

Pharmakon Laboratory, Inc.

• Order (PDF - 19KB) (July 25, 2005)
• Order of Permanent Injunction (PDF - 215KB) (July 25, 2005)

Pharma Pac Inc.

• Warning Letter (Issued April 27, 2009)

PrimaPharm Inc.

• Warning Letter (Issued October 31, 2008)

Provident Pharmaceuticals LLC

• Warning Letter (Issued November 9, 2009)

River's Edge Pharmaceuticals, LLC

• Warning Letter (Issued May 20, 2010)

RGH & Company Inc., dba Vital Nutrients

• Warning Letter (Issued November 18, 2008)

Scientific Laboratories, Inc.

• FDA News: FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. (Issued May 16, 2008)
• Warning Letter (Issued November 16, 2005)
• Consent Decree of Permanent Injunction (PDF - 618KB) (May 8, 2008)

Sheffield Laboratories, Division of Faria Limited LLC

• Warning Letter (Issued July 24, 2006)

Sunrise Pharmaceutical, Inc.

• Warning Letter (Issued January 14, 2010)

Syntho Pharmaceuticals, Inc. and Intermax Pharmaceuticals, Inc.

• FDA News: FDA Continues To Tackle Unapproved Drugs (Issued October 5, 2006)
• Consent Decree of Permanent Injunction (PDF - 862KB) (August 10, 2006)
• FDA Complaint for Permanent Injunction (PDF - 348KB) (August 10, 2006)
• Warning Letter (Issued May 13, 2003)
• Warning Letter (Issued March 14, 2003)

Time-Cap Laboratories, Inc.

• Warning Letter (April 10, 2009)

Tri-Med Laboratories, Inc.

• Warning Letter (February 23, 2010)
• Consent Decree of Permanent Injunction (PDF - ) (March 2011)

Vintage Pharmaceuticals, LLC

• Warning Letter (Issued February 1, 2008)

Vita-Erb, Ltd.

• Order of Permanent Injunction (PDF - 348KB) (Filed November 14, 2006)
• FDA Supplemental Complaint for Permanent Injunction (PDF - 77KB) (Filed June 9, 2006)
• Warning Letter (Issued April 29, 2004)