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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2013 Warning Letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
June 10, 2013 San Diego Cold Storage Dallas District Office Insanitary Conditions/Adulterated Not Issued *
June 10, 2013 Muxlow Dairy Detroit District Office Illegal Drug Residue March 24, 2014
June 07, 2013 Alma Lasers, Inc. Chicago District Office Medical Device Reporting/Misbranded January 30, 2014
June 06, 2013 Constanza Agroindustrial, S.R.I. Center for Food Safety and Applied Nutrition Acidified Foods/Acid Canned Food Regulation/Adulterated July 11, 2013
June 06, 2013 S Serra Cheese Company Detroit District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
June 06, 2013 MEDINVENTS NV Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded December 09, 2014
June 06, 2013 Ardounie Farms Philadelphia District Office Illegal Drug Residue December 05, 2013
June 05, 2013 Frazer, Henry A. Pharm D Center for Drug Evaluation and Research Clinical Investigator Not Issued *
June 05, 2013 Automated Ophthalmics, Inc. Baltimore District Office CGMP/QSR/Medical Devices/Adulterated February 18, 2014
June 05, 2013 Baarda Farms Seattle District Office Illegal Drug Residue Not Issued *
June 04, 2013 Cara Donna Provision Company New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 30, 2014
June 04, 2013 Annasea International Hawaii, LLC San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 04, 2013 Techlem Medical Corporation Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
June 04, 2013 Changzhou Qianhong Bio-Pharma Co., Ltd Center for Drug Evaluation and Research Failure to Register and List July 09, 2013
June 03, 2013 www.alstobacco.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 07, 2013
June 03, 2013 Roest Family Dairy San Francisco District Office Illegal Drug Residue Not Issued *
May 31, 2013 SpineNet Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 31, 2013 Baxter Healthcare Corporation Atlanta District Office CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated Not Issued *
May 30, 2013 Watson Dairy New Orleans District Office New Animal Drug/Adulterated Not Issued *
May 30, 2013 Kerber, Inc. Philadelphia District Office Labeling/False & Misleading Claims/Misbranded December 17, 2013

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