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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 30, 2011 NAImco Inc dba Richmar Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 30, 2011 Okamoto Rubber Products Co., Ltd. Center for Devices and Radiological Health Medical Device Reporting/Misbranded June 07, 2012
December 29, 2011 Changzhou Jialing Medicine Industry Co Ltd Center for Drug Evaluation and Research Failure to Register and List Not Issued *
December 29, 2011 Sharn, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 28, 2011 Midmark Corporation Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 28, 2011 Natural Health Team New Orleans District Office Unapproved New Drug Not Issued *
December 28, 2011 Vaughan Foods Inc. (Allison's Gourmet Kitchen) Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 24, 2013
December 28, 2011 Jang Soo Farm Inc. dba Rainier Sprouts, Inc. Seattle District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions February 28, 2013
December 28, 2011 Greencore OARS, LLC New England District Office Seafood HACCP/CGMP for Foods/Adulterated /Sanitation July 31, 2012
December 27, 2011 Intersurgical, Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Misbranded April 27, 2012
December 27, 2011 Encompass Group, LLC New Orleans District Office CGMP/QSR/Medical Devices/Adulterated September 18, 2012
December 27, 2011 Animas Corporation Philadelphia District Office Medical Device Reporting/Misbranded May 22, 2013
December 27, 2011 San-J International, Inc. Baltimore District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated September 05, 2012
December 23, 2011 Go Medical Industries Pty., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
December 23, 2011 Les Laboratoires Blanchard Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Misbranded June 24, 2014
December 23, 2011 Teh Lin Prosthetic & Orthopedic, Inc. Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
December 23, 2011 PT. Intimas Surya Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
December 23, 2011 Pure Encapsulations, Inc. New England District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated September 02, 2014
December 23, 2011 Wendy Weihe Storlie, Inc. Minneapolis District Office Animal Food/Misbranded/Labeling June 04, 2013
December 23, 2011 APC Medical Limited Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *



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