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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2012 Warning Letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
June 04, 2012 lnnovision A/S Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated February 20, 2014
June 01, 2012 Fenwal, a Fresenius-Kaby Company Center for Biologics Evaluation and Research False & Misleading Claims/Misbranded May 07, 2013
June 01, 2012 Weld County Bi-Products dba Fort Morgan Pet Foods Denver District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded Not Issued *
June 01, 2012 Wannemacher Enterprises Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 30, 2013
June 01, 2012 Woolery Enterprises, Inc. Dba Will's Fresh Foods San Francisco District Office Seafood HACCP/Adulterated Not Issued *
June 01, 2012 www.mangga-dua.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded June 15, 2012
June 01, 2012 Snellman Farms Cincinnati District Office Illegal Drug Residue Not Issued *
June 01, 2012 Advocate Health Care Center for Drug Evaluation and Research Institutional Review Board (IRB) April 29, 2014
June 01, 2012 www.kretek-taste.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded June 15, 2012
June 01, 2012 Our Lady of Bellefonte Hospital Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
May 31, 2012 Changzhou Wujin Zhengping Shuangma Chemical Plant Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
May 30, 2012 Nicalapia S.A. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
May 29, 2012 Siemens Healthcare Diagnostics New York District Office CGMP/QSR/Medical Devices/Adulterated July 17, 2013
May 29, 2012 Argentum Medical LLC Center for Devices and Radiological Health Misbranding Not Issued *
May 29, 2012 Albert Browne Ltd. Center for Devices and Radiological Health Adulterated Device Not Issued *
May 25, 2012 Elizabeth E. Houser, MD Center for Drug Evaluation and Research Clinical Investigator Not Issued *
May 24, 2012 NatureMost of New England, Inc. New England District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
May 24, 2012 DMC Medical Ltd Center for Devices and Radiological Health CGMP for Medical Devices/QS/Adulterated Not Issued *
May 24, 2012 Best Price Rx Center for Drug Evaluation and Research Unapproved/Misbranded New Drug June 28, 2012
May 24, 2012 Himalayan Int'l Inst. of Yoga Science and Phil. of the USA Philadelphia District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated June 04, 2013



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