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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2009 Warning Letters

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Warning Letters issued in 2009

 

* 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
May 06, 2009 Synkem Center for Drug Evaluation and Research CGMP for Deviations/Adulterated N/A *
May 06, 2009 www.extremeimmunity.com Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 06, 2009 Elkhart General Hospital Blood Donor Center Detroit District Office CGMP Regulations for Blood and Blood Components N/A *
May 05, 2009 Muvezi Inc. Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 05, 2009 The Secrets of Eden Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 05, 2009 General Mills, Inc. Minneapolis District Office Promotional Claims False & Misleading/Misbranded N/A *
May 05, 2009 Stryker Craniomaxillofacial Division Detroit District Office Premarket Approval/Misbranded/Adulterated N/A *
May 05, 2009 Susan Ambrosino's Herb Club, Inc. www.myherbs.net Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 04, 2009 Shaheen Brothers, Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
May 04, 2009 Rainbow Springs LLC, dba Star Prairie Trout Farm Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
May 03, 2009 Rebuilder Medical Technology, Inc Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
April 27, 2009 Nostrum Laboratories Inc Kansas City District Office CGMP/Deviations/Adulterated N/A *
April 27, 2009 Hill Dermaceuticals, Inc. Florida District Office CGMP for Finished Pharmaceutical/Adulterated N/A *
April 27, 2009 Pharma Pac LLC New Orleans District Office CGMP for Deviations/Adulterated N/A *
April 24, 2009 Olay LLC. San Juan District Office CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated N/A *
April 23, 2009 Central Peninsula General Hospital - Kenai Clinic Seattle District Office Mammography Quality Standards Act N/A *
April 22, 2009 Dabur Oncology PLC Center for Drug Evaluation and Research CGMP for Finished Pharmaceutical/Adulterated N/A *
April 22, 2009 Borkholder Farms Detroit District Office Illegal Drug Residue N/A *
April 21, 2009 Marina Medical Instruments Inc. Florida District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded N/A *
April 20, 2009 Francisco Hernandez, M.D. Center for Drug Evaluation and Research Clinical Investigator N/A *



 

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