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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 12, 2009 Quake Kare, Inc. Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 12, 2009 Boss Innovation & Marketing, Inc. Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 12, 2009 Howard Instruments Inc. 5/12/09 New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
May 12, 2009 Pyng Medical Corporation Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded N/A *
May 12, 2009 Amyron Enterprises Pty Ltd. Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 12, 2009 Whole World Botanicals Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 12, 2009 LifeSecure Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 12, 2009 Healthy Choice Naturals Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 11, 2009 Nexera Medical Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 11, 2009 Becton Dickinson & Company 5/11/09 Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 11, 2009 R4 LLC Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
May 11, 2009 Ageless Herbs Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 11, 2009 Prodesse, Inc Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 08, 2009 VitaCroft, LLP Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 07, 2009 Lupin Limited Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
May 07, 2009 L.P. Wholesale Seafood, Ltd. New York District Office Seafood HACCP/Adulterated N/A *
May 07, 2009 Samglo Enterprises Detroit District Office Promotional Claims False & Misleading/Misbranded N/A *
May 07, 2009 Vaccaro's Italian Pastry Shop, Inc. Baltimore District Office Current Good Manufacturing Practice Regulations for Human Foods/Adulterated N/A *
May 07, 2009 Hearn-Kirkwood Incorporated Baltimore District Office Seafood HACCP/Adulterated/Misbranded N/A *
May 06, 2009 Eureka Springs Hospital 5/6/09 Dallas District Office Mammography Quality Standards Act N/A *



 

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