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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

Posted on July 13, 2010

Letter Issue Date Company Name Issuing Office Subject Close Out Date
July 06, 2010 Country Road Veterinary Services LLC Cincinnati District Office New Animal Drug/Adulterated/Labeling/Misbranded September 01, 2010
July 06, 2010 Western Milling Company Los Angeles District Office CGMP for Medicated Feeds/Adulterated/Misbranded Not Issued *
July 02, 2010 Regancrest Holsteins, Inc. Kansas City District Office Extralabel Drug Use in Animals/Adulterated 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 Steril Aire Center for Devices and Radiological Health Premarket Approval/Adulterated/Misbranded Not Issued *
June 30, 2010 Haldiman, Keith And Patricia Minneapolis District Office Animal for Slaughter for Food/Adulterated November 15, 2010
June 28, 2010 Arasys Perfector Inc Center for Devices and Radiological Health Medical Device Reporting (MDR) Regulation Misbranded/Adulterated January 31, 2011
June 28, 2010 Hi-Tech Pharmacal Co., Inc. New York District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded September 05, 2011
June 28, 2010 Nemechek Do Pa, Patrick Center for Biologics Evaluation and Research Clinical Investigator July 29, 2010


 

Contact FDA

301-796-8490
FDA's Office of Critical Path Programs
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