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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 30, 2010 Dr. Christopher's Denver District Office Drug Products/Therapeutic Claims Not Issued *
December 28, 2010 McGuff Pharmaceuticals Inc. Los Angeles District Office Current Good Manufacturing Practice for Finished Pharmaceuticals/Misbranded/Adulterated April 25, 2012
December 28, 2010 Novacare, LLC Denver District Office Unapproved New Drugs/Misbranded Dietary Supplements Not Issued *
December 28, 2010 Pacific Exchange Distributors, Llc Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
December 23, 2010 Syneron, Inc Los Angeles District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)/Misbranded April 03, 2012
December 22, 2010 Abon Biopharm (Hangzhou) Co., Ltd Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated October 16, 2012
December 22, 2010 Vistar Corporation Florida District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
December 22, 2010 Heritage Labs International LLC Kansas City District Office Premarket Approval/Adulterated/Misbranded July 14, 2011
December 22, 2010 Aqueduct Medical, Inc. San Francisco District Office Lacks Premarket Approval Application/Adulterated/Misbranded Not Issued *
December 22, 2010 Access Bio, Inc. New Jersey District Office Lacks Premarket Approval/Adulterated Not Issued *
December 22, 2010 Bauer & Hasselbarth Gmbh Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated January 11, 2012
December 21, 2010 Natural Options Corp Florida District Office New Drug/Adulterated/Misbranded Not Issued *
December 21, 2010 Klinge Chemicals Limited Center for Drug Evaluation and Research CGMP for Deviations/Adulterated October 22, 2012
December 21, 2010 Smith & Nephew Orthopaedics Gmbh Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated June 20, 2013
December 21, 2010 Tico's Mexican Foods, inc. Denver District Office Seafood HACCP/Insanitary Conditions/Adulterated Not Issued *
December 21, 2010 Natural Zing, LLC Baltimore District Office Unapproved New Drug Promotional Claims/Misbranded Not Issued *
December 21, 2010 CIBA Vision Puerto Rico, Inc. San Juan District Office CGMP/QSR/Medical Devices/Adulterated September 14, 2011
December 20, 2010 Peregrine Surgical Ltd Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 20, 2010 Wild Thymes Farm, Inc. New York District Office Acidified Foods/Adulterated Not Issued *
December 16, 2010 Synbiotics Ltd Center for Drug Evaluation and Research CGMP for Deviations/Adulterated 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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