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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
March 01, 2010 Edwards Lifesciences, LLC Center for Devices and Radiological Health Device/Misbranded Not Issued *
March 01, 2010 Paddock Laboratories, Inc. Center for Drug Evaluation and Research New Drugs Not Issued *
February 26, 2010 Guidewire Technologies, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated September 28, 2010
February 25, 2010 Cucina Fresca, Inc. Seattle District Office Seafood HACCP Not Issued *
February 25, 2010 Olympus Temmo Biomaterials Corporation - Mishima Factory Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
February 24, 2010 Acquired Holding Inc Cincinnati District Office Seafood HACCP Not Issued *
February 24, 2010 Mueller Water Conditioning, Inc Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
February 24, 2010 Centrix Pharmaceutical Inc New Orleans District Office New Drug/Adulterated Not Issued *
February 23, 2010 Tri-Med Laboratories Inc New Jersey District Office Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals Not Issued *
February 23, 2010 Arnold's Service Company, Inc. Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the 2009 H1N1 Flu Virus Not Issued *
February 23, 2010 Seoul Trading Inc Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
February 23, 2010 Arnold's Service Company, Inc. Center for Devices and Radiological Health UnapprovedlUncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
February 23, 2010 Karl Storz Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
February 23, 2010 Pom Wonderful Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 23, 2010 HMI Industries, Inc. Cincinnati District Office CGMP/QSR/Adulterated/Misbranded Not Issued *
February 22, 2010 Beech-Nut Nutrition Corporation Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Guangzhou Yong Want Foods Ltd Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Schwan's Consumer Brands Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Sunsweet Growers Inc Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Gerber Products Company Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded 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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