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 October 26, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
October 20, 2010	Lippton, Howard M.D.	Center for Drug Evaluation and Research	Clinical Investigator	Not Issued *
October 20, 2010	Pacific Fishing Company Limited	Center for Food Safety and Applied Nutrition	CGMP for Foods/Seafood HACCP/Adulterated	Not Issued *
October 20, 2010	Vita-Herb Nutriceuticals, Inc.	Los Angeles District Office	CGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated	Not Issued *
October 20, 2010	Scott, David F., M.D.	Center for Drug Evaluation and Research	Clinical Investigator	Not Issued *
October 20, 2010	Axis Health Care LLC	New Orleans District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	Not Issued *
October 18, 2010	Mead Johnson Nutrition Company	Detroit District Office	Infant Formula/Labeling	December 03, 2010
October 15, 2010	Quality Egg LLC	Kansas City District Office	PHS Act Violation/Adulterated	Not Issued *
October 15, 2010	Lighthouse Marina Partnership	New Jersey District Office	Seafood HACCP	Not Issued *
October 15, 2010	Yunnan Hande Bio-Tech. Co. Ltd.	Center for Drug Evaluation and Research	CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated	October 25, 2011
October 15, 2010	Living Naturally	Florida District Office	New Drug/Adulterated/Misbranded	Not Issued *

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