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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2011 Warning Letters

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Warning Letters issued in 2011

 

* 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 January 17, 2012

Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 22, 2011 Ever Cat Fuels, LLC Minneapolis District Office Food Additive/Adulterated/Misbranded Not Issued *
December 21, 2011 Integra LifeSciences Corporation New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 21, 2011 The hCG Drops, LLC Denver District Office Homeopathic HCG Initiative Not Issued *
December 20, 2011 MedPharm, LLC New Orleans District Office Import for Export (IFE) Not Issued *
December 20, 2011 Four Star Import & Distribution New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions May 24, 2012
December 20, 2011 Bay Regional Medical Center IRB Center for Drug Evaluation and Research IRB (Institutional Review Board) Not Issued *
December 20, 2011 Diagnostics Biochem Canada, Inc. Center for Devices and Radiological Health CGMP for Medical Devices/QS/Adulterated Not Issued *
December 19, 2011 Best Express Foods, Inc. Detroit District Office CGMP for Food/Adulterated Not Issued *
December 19, 2011 Milk Specialties Global - Wautoma Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
December 19, 2011 NeuroScience, Inc. Minneapolis District Office Labeling/False & Misleading Claims/Misbranded November 30, 2012
December 19, 2011 Satyaprakash N. Makam, MD Center for Devices and Radiological Health Investigational Review Board (IRB)/Medical Devices Not Issued *
December 16, 2011 Mikilua Poultry Farm Inc. San Francisco District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
December 16, 2011 Newman Lasik Centers, LLC Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
December 16, 2011 The Lasik Vision Institute Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded August 17, 2012
December 15, 2011 KBD, Inc. Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 15, 2011 Labor L+S AG Center for Drug Evaluation and Research CGMP for Finished Pharmaceutical/Adulterated Not Issued *
December 15, 2011 Merck KGaA Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
December 15, 2011 Merck KGaA, Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
December 14, 2011 The Cake Box, Inc. San Francisco District Office CGMP Regulation For Food/Adulterated Not Issued *
December 14, 2011 Nenningers Naturals, LLC New York District Office False & Misleading Claims/New Drug/Misbranded Not Issued *


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