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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
June 09, 2010 Busman Dairy Seattle District Office Illegal Drug Residue Not Issued *
June 08, 2010 Homeopathy For Health Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
June 08, 2010 Piezosurgery Inc. Cincinnati District Office CGMP for Medical Devices/QS/Adulterated March 29, 2011
June 07, 2010 Arizant Inc Center for Devices and Radiological Health CGMP/QSR/Medical Device Reporting/Misbranded Not Issued *
June 07, 2010 Mamma Lina's, Inc. Los Angeles District Office Seafood HACCP/Adulterated October 06, 2011
June 07, 2010 Dick-mar Farms Philadelphia District Office Illegal Drug Residue Not Issued *
June 04, 2010 Atlas Operations, Inc. Florida District Office CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated Not Issued *
June 04, 2010 Troyer Farms Detroit District Office Animal Sale for Slaughter as Food/Adulterated April 01, 2011
June 03, 2010 Baxter Healthcare Corporation Chicago District Office Medical Device Reporting (MDR) Regulation/Adulterated Not Issued *
June 03, 2010 Twin Oaks Community Foods, Inc Baltimore District Office Food Labeling/Misbranded July 19, 2011
June 02, 2010 Swinefludefence.org Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
June 02, 2010 Fludefence.org Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
June 02, 2010 Saurabh Overseas Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
June 02, 2010 Fiesta Gourmet and Deli Detroit District Office Seafood HACCP/Adulterated Not Issued *
June 02, 2010 Encompass Group, LLC Atlanta District Office Medical Device Reporting (MDR) Regulation Misbranded Not Issued *
June 02, 2010 Privacyprotect.org Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
June 01, 2010 Tejas Industries Inc. Dallas District Office Pet Treats for Sale as Food/Adulterated Not Issued *
June 01, 2010 Sivertson Fisheries Inc Minneapolis District Office Seafood HACCP Not Issued *
May 28, 2010 American Sea Food Company, Inc. Los Angeles District Office Seafood HACCP/Adulterated Not Issued *
May 28, 2010 Yancey, Samuel DVM New York District Office Illegal Drug Residue 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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