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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
12/30/2011 NAImco Inc dba Richmar Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
12/30/2011 Okamoto Rubber Products Co., Ltd. [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting/Misbranded 06/07/2012
12/29/2011 Sharn, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
12/29/2011 Changzhou Jialing Medicine Industry Co Ltd [ARCHIVED] Center for Drug Evaluation and Research Failure to Register and List Not Issued *
12/28/2011 Natural Health Team [ARCHIVED] New Orleans District Office Unapproved New Drug Not Issued *
12/28/2011 Midmark Corporation [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
12/28/2011 Vaughan Foods Inc. (Allison's Gourmet Kitchen) [ARCHIVED] Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 01/24/2013
12/28/2011 Jang Soo Farm Inc. dba Rainier Sprouts, Inc. [ARCHIVED] Seattle District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 02/28/2013
12/28/2011 Greencore OARS, LLC [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated /Sanitation 07/31/2012
12/27/2011 Encompass Group, LLC [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated 09/18/2012
12/27/2011 Intersurgical, Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Misbranded 04/27/2012
12/27/2011 San-J International, Inc. [ARCHIVED] Baltimore District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated 09/05/2012
12/27/2011 Animas Corporation [ARCHIVED] Philadelphia District Office Medical Device Reporting/Misbranded 05/22/2013
12/23/2011 PT. Intimas Surya [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
12/23/2011 Teh Lin Prosthetic & Orthopedic, Inc. [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
12/23/2011 Go Medical Industries Pty., Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
12/23/2011 Wendy Weihe Storlie, Inc. [ARCHIVED] Minneapolis District Office Animal Food/Misbranded/Labeling 06/04/2013
12/23/2011 Les Laboratoires Blanchard [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Misbranded 06/24/2014
12/23/2011 Pure Encapsulations, Inc. [ARCHIVED] New England District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 09/02/2014
12/23/2011 APC Medical Limited [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
12/22/2011 Ever Cat Fuels, LLC [ARCHIVED] Minneapolis District Office Food Additive/Adulterated/Misbranded 06/05/2013
12/21/2011 The hCG Drops, LLC [ARCHIVED] Denver District Office Homeopathic HCG Initiative Not Issued *
12/21/2011 Integra LifeSciences Corporation [ARCHIVED] New Jersey District Office CGMP/QSR/Medical Devices/Adulterated 09/24/2013
12/20/2011 Diagnostics Biochem Canada, Inc. [ARCHIVED] Center for Devices and Radiological Health CGMP for Medical Devices/QS/Adulterated Not Issued *
12/20/2011 MedPharm, LLC [ARCHIVED] New Orleans District Office Import for Export (IFE) Not Issued *
12/20/2011 Four Star Import & Distribution [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 05/24/2012
12/20/2011 Bay Regional Medical Center IRB [ARCHIVED] Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
12/19/2011 Satyaprakash N. Makam, MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials Not Issued *
12/19/2011 Best Express Foods, Inc. [ARCHIVED] Detroit District Office CGMP for Food/Adulterated 04/15/2014
12/19/2011 NeuroScience, Inc. [ARCHIVED] Minneapolis District Office Labeling/False & Misleading Claims/Misbranded 11/30/2012
12/19/2011 Milk Specialties Global - Wautoma [ARCHIVED] Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 09/19/2014
12/16/2011 The Lasik Vision Institute [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 08/17/2012
12/16/2011 Mikilua Poultry Farm Inc. [ARCHIVED] San Francisco District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
12/16/2011 Newman Lasik Centers, LLC [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
12/15/2011 Merck KGaA [ARCHIVED] Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 03/18/2014
12/15/2011 Labor L+S AG [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceutical/Adulterated 04/24/2013
12/15/2011 KBD, Inc. [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
12/14/2011 The Cake Box, Inc. [ARCHIVED] San Francisco District Office CGMP Regulation For Food/Adulterated Not Issued *
12/14/2011 Nenningers Naturals, LLC [ARCHIVED] New York District Office False & Misleading Claims/New Drug/Misbranded 09/19/2013
12/13/2011 Woeber Mustard Manufacturing Co Inc [ARCHIVED] Cincinnati District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
12/13/2011 CPR Medical Devices, Inc. [ARCHIVED] Center for Devices and Radiological Health Quality System Regulation/Adulterated Not Issued *
12/13/2011 Kencor Ethnic Foods, Inc [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 07/16/2012
12/13/2011 Atlantic Pro Nutrients, Inc. dba XYMOGEN [ARCHIVED] Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 08/21/2012
12/12/2011 Lone Star Lions Eye Bank [ARCHIVED] Dallas District Office Human Cells, Tissues & Cellular Products 05/25/2012
12/12/2011 1 800 Get Thin LLC [ARCHIVED] Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
12/12/2011 Gilroy Spice Company [ARCHIVED] San Francisco District Office Acidified Foods/Acid Canned Food Regulation/Adulterated/Misbranded Not Issued *
12/09/2011 J. DeLuca Fish Company, Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
12/09/2011 Light-Tech, Inc. [ARCHIVED] Florida District Office Medical Device Reporting/Misbranded Not Issued *
12/09/2011 Spencer Forrest, Inc. [ARCHIVED] Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded Not Issued *
12/09/2011 CuraeLase, Inc. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *

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