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

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