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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2010 Warning Letters

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Warning Letters issued in 2010

 

* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

Posted on July 13, 2010

Letter Issue Date Company Name Issuing Office Subject Close Out Date
May 27, 2010 Industrias Alimentarias De Navarra, S.A.U. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated September 16, 2010
May 27, 2010 Italco Food Products, Inc. Denver District Office Seafood HACCP/Adulterated August 05, 2011
May 27, 2010 Ribbon SRL Center for Drug Evaluation and Research CGMP Regulation for Finished Pharmaceuticals/Adulterated April 18, 2011
May 26, 2010 Pfizer, Inc. New York District Office Postmarketing Adverse Drug Experience Reporting Requirements Not Issued *
May 25, 2010 Pharmline, Inc. New York District Office Federal Food, Drug, and Cosmetic Act Violations/Radiation/Adulterated/Misbranded Not Issued *
May 25, 2010 Flexcin International, Inc. Florida District Office New Drug/Labeling/False & Misleading Claims Not Issued *
May 25, 2010 Toby's Nose Filters, Inc. Florida District Office Premarket Approval/Adulterated Not Issued *
May 25, 2010 Tom Schantz Farm (d/b/a Riverview Dale Farm) New York District Office Illegal Drug Residue Not Issued *
May 24, 2010 Syntron Bioresearch Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Device Reporting/Adulterated Not Issued *
May 21, 2010 Mickey's Snacks & Concession Supply Co. Florida District Office Food Labeling/Misbranded October 06, 2010
May 21, 2010 AVEVA Drug Delivery Systems, Inc. Florida District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
May 21, 2010 Feel Good Natural Health Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
May 21, 2010 Dexcom Inc Los Angeles District Office Medical Device Reporting/Misbranded July 15, 2011
May 21, 2010 K. C. Pharmaceuticals Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Finished Pharmaceuticals/Adulterated Not Issued *
May 21, 2010 Amigo Mobility International, Inc Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 21, 2010 Zone Of Natural Remedies Center for Drug Evaluation and Research Unapproved/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
May 21, 2010 David Montanez Calf Farm Dallas District Office Illegal Drug Residue Not Issued *
May 20, 2010 Hyperbaric for Life LLC Los Angeles District Office Medical Device Reporting Regulation/Misbranded July 15, 2011
May 20, 2010 River's Edge Pharmaceuticals, LLC Atlanta District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
May 17, 2010 A Simoes Family Dairy Los Angeles District Office Illegal Drug Residue Not Issued *


 

Contact FDA

FDA's Office of Critical Path and Regulatory Science Initiatives

Frank F. Weichold, MD, PhD

Acting Director

Critical Path and Regulatory Science Initiatives

301-796-8187

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