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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
November 26, 2010 Shi Feng Zhang Dba Ginseng88 Center for Food Safety and Applied Nutrition False & Misleading Claims/Misbranded Not Issued *
November 24, 2010 Sagami Rubber Industries Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated September 21, 2011
November 24, 2010 Eagle Health Supplies, Inc. Los Angeles District Office CGMP/QS/Adulterated November 06, 2012
November 22, 2010 WalkMed Infusion, LLC Denver District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 19, 2010 Fujino Enterprises, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
November 18, 2010 AES Optics New Orleans District Office CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation Not Issued *
November 18, 2010 VanderVeer Center Center for Drug Evaluation and Research Misbranded/Labeling/Unauthorized Health Claims July 26, 2011
November 17, 2010 Phusion Projects Inc. Center for Food Safety and Applied Nutrition Illegal Food Additive/Adulteration Not Issued *
November 17, 2010 Charge Beverages Corporation Center for Food Safety and Applied Nutrition Illegal Food Additive/Adulteration Not Issued *
November 17, 2010 United Brands Company Inc Center for Food Safety and Applied Nutrition Illegal Food Additive/Adulteration Not Issued *
November 17, 2010 Bobby Chez, Inc. New Jersey District Office Seafood HACCP February 24, 2012
November 17, 2010 YeYa Products Corp Florida District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
November 17, 2010 New Century Brewing Co Center for Food Safety and Applied Nutrition Illegal Food Additive/Adulteration Not Issued *
November 17, 2010 Align Technology Inc San Francisco District Office Device/Misbranded Not Issued *
November 16, 2010 Empresas Y-nuina, Inc. San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions June 10, 2014
November 16, 2010 Eastern Cranial Affiliates, LLC Baltimore District Office CGMP/QSR/Medical Device Reporting/Misbranded June 08, 2011
November 15, 2010 Fischer Surgical Inc Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated December 19, 2011
November 12, 2010 Artesian Trout Farm Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Misbranded May 08, 2012
November 10, 2010 Eagle Products Chicago District Office Current Good Manufacturing Practice Regulations for Human Foods/Adulterated April 04, 2012
November 10, 2010 Kabco Pharmaceuticals, Inc. New York District Office CGMP in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements/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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