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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2012 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
June 01, 2012 Wannemacher Enterprises Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 30, 2013
June 01, 2012 Fenwal, a Fresenius-Kaby Company Center for Biologics Evaluation and Research False & Misleading Claims/Misbranded May 07, 2013
June 01, 2012 Our Lady of Bellefonte Hospital Center for Drug Evaluation and Research Investigational Review Board (IRB) Not Issued *
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 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 Woolery Enterprises, Inc. Dba Will's Fresh Foods San Francisco District Office Seafood HACCP/Adulterated Not Issued *
June 01, 2012 Snellman Farms Cincinnati District Office Illegal Drug Residue 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 Advocate Health Care Center for Drug Evaluation and Research Investigational 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 Albert Browne Ltd. Center for Devices and Radiological Health Adulterated Device Not Issued *
May 29, 2012 Argentum Medical LLC Center for Devices and Radiological Health Misbranding Not Issued *
May 25, 2012 Elizabeth E. Houser, MD Center for Drug Evaluation and Research Clinical Investigator Not Issued *
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
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 Faci S.P.A. Center for Drug Evaluation and Research Failure to Register and List June 14, 2012
May 24, 2012 Northwest Pharmacy Center for Drug Evaluation and Research Unapproved New Drug-Misbranded June 28, 2012



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