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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
July 06, 2010 Western Milling Company Los Angeles District Office CGMP for Medicated Feeds/Adulterated/Misbranded Not Issued *
July 06, 2010 Triple G Dairy Los Angeles District Office Animal Sale for Slaughter as Food/Adulterated August 05, 2010
July 02, 2010 Steril Aire Center for Devices and Radiological Health Premarket Approval/Adulterated/Misbranded Not Issued *
July 02, 2010 Replication Medical Inc Center for Devices and Radiological Health Medical Device/Lacks Premarket Approval/Adulterated/Misbranded November 23, 2010
July 02, 2010 Abbott Diabetes Care, Inc. San Francisco District Office CGMP for Medical Devices/QS/Adulterated Not Issued *
July 02, 2010 Regancrest Holsteins, Inc. Kansas City District Office Extralabel Drug Use in Animals/Adulterated Not Issued *
June 30, 2010 Haldiman, Keith And Patricia Minneapolis District Office Animal for Slaughter for Food/Adulterated November 15, 2010
June 28, 2010 Nemechek Do Pa, Patrick Center for Biologics Evaluation and Research Clinical Investigator July 29, 2010
June 28, 2010 Hi-Tech Pharmacal Co., Inc. New York District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded September 05, 2011
June 28, 2010 Arasys Perfector Inc Center for Devices and Radiological Health Medical Device Reporting (MDR) Regulation Misbranded/Adulterated January 31, 2011
June 25, 2010 Pozner, Jason M.D. Center for Devices and Radiological Health Investigational Device Exemptions (Clinical Investigator) Not Issued *
June 25, 2010 AMPAC Fine Chemicals, LLC San Francisco District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated April 25, 2011
June 25, 2010 American Pecan Co. LLC Dallas District Office CGMP for Foods/Labeling/Adulterated/Misbranded Not Issued *
June 24, 2010 Thumb Oilseed Producers' Cooperative Detroit District Office CGMP Regulation For Food/Adulterated Not Issued *
June 24, 2010 North Memorial Medical Center Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
June 23, 2010 Blountys, LLC Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
June 23, 2010 Oregon Health & Science University Seattle District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products Not Issued *
June 23, 2010 Basic Food Flavors, Inc. San Francisco District Office CGMP/Foods/Insanitary Conditions Not Issued *
June 22, 2010 MedCentral Health System Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
June 22, 2010 Nanjing Pharmaceutical Factory Company Limited Center for Veterinary Medicine CGMP/Active Pharmaceutical Ingredient Manufacturing Facility/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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