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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
06/11/2012 Beekley Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated 06/23/2015
06/11/2012 Brouillette Farm, Inc. New England District Office Illegal Drug Residue Not Issued *
06/11/2012 Bausch & Lomb ELC SPL Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded Not Issued *
06/08/2012 Endogastric Solutions, Inc. Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization Not Issued *
06/08/2012 Michelle's Miracle, Inc. Detroit District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded 05/03/2013
06/07/2012 Oza Compound Products, LLC Detroit District Office CGMP for Dietary Supplement/Adulterated/Misbranded Not Issued *
06/07/2012 New Life Corporation Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
06/05/2012 J.C. Maurer & Sons Minneapolis District Office Illegal Drug Residue 07/09/2012
06/05/2012 Nevyas Eye Associates Center for Devices and Radiological Health Misbranding Not Issued *
06/05/2012 Michigan Medical Innovations Detroit District Office CGMP/QSR/Medical Devices/Adulterated 06/06/2013
06/05/2012 CardioMEMS, Inc. Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization Not Issued *
06/05/2012 Koenen Dairy Inc Kansas City District Office Illegal Drug Residue Not Issued *
06/05/2012 Hijos De Carlos Albo S.L. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
06/04/2012 Van Ess Dairy LLC Kansas City District Office Illegal Drug Residue Not Issued *
06/04/2012 lnnovision A/S Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 02/20/2014
06/01/2012 Fenwal, a Fresenius-Kaby Company Center for Biologics Evaluation and Research False & Misleading Claims/Misbranded 05/07/2013
06/01/2012 Weld County Bi-Products dba Fort Morgan Pet Foods Denver District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded Not Issued *
06/01/2012 Wannemacher Enterprises Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 01/30/2013
06/01/2012 Woolery Enterprises, Inc. Dba Will's Fresh Foods San Francisco District Office Seafood HACCP/Adulterated Not Issued *
06/01/2012 www.mangga-dua.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 06/15/2012
06/01/2012 Snellman Farms Cincinnati District Office Illegal Drug Residue Not Issued *
06/01/2012 Advocate Health Care Center for Drug Evaluation and Research Institutional Review Board (IRB) 04/29/2014
06/01/2012 www.kretek-taste.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 06/15/2012
06/01/2012 Our Lady of Bellefonte Hospital Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
05/31/2012 Changzhou Wujin Zhengping Shuangma Chemical Plant Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
05/30/2012 Nicalapia S.A. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
05/29/2012 Siemens Healthcare Diagnostics New York District Office CGMP/QSR/Medical Devices/Adulterated 07/17/2013
05/29/2012 Argentum Medical LLC Center for Devices and Radiological Health Misbranding Not Issued *
05/29/2012 Albert Browne Ltd. Center for Devices and Radiological Health Adulterated Device Not Issued *
05/25/2012 Houser, Elizabeth E. MD Center for Drug Evaluation and Research Clinical Investigator Not Issued *
05/24/2012 NatureMost of New England, Inc. New England District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
05/24/2012 DMC Medical Ltd Center for Devices and Radiological Health CGMP for Medical Devices/QS/Adulterated Not Issued *
05/24/2012 Best Price Rx Center for Drug Evaluation and Research Unapproved/Misbranded New Drug 06/28/2012
05/24/2012 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 06/04/2013
05/24/2012 Good Herbs, Inc. Detroit District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
05/24/2012 De Groot Sheep Inc Kansas City District Office Illegal Drug Residue 07/31/2013
05/24/2012 Northwest Pharmacy Center for Drug Evaluation and Research Unapproved New Drug-Misbranded 06/28/2012
05/24/2012 Faci S.P.A. Center for Drug Evaluation and Research Failure to Register and List 06/14/2012
05/24/2012 FairPrice Tobacco, Inc d/b/a www. RYOCigarette.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 08/13/2012
05/23/2012 RockStar, Inc. DBA Livingston Chocolate Company New Orleans District Office Unapproved Food Additive/Adulterated Not Issued *
05/23/2012 Tango3 LLC Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
05/22/2012 Ernest P. Shoup Farm Cincinnati District Office Illegal Drug Residue Not Issued *
05/22/2012 Mc-NEIL-PPC, Inc. New Jersey District Office Adulterated Device 05/22/2014
05/22/2012 Malcolm, Matthew PhD., OTR Center for Devices and Radiological Health Sponsor-Investigator Not Issued *
05/21/2012 Nicho Produce Co., Inc. Dallas District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
05/21/2012 Smith Family Frosted Foods LLC Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
05/18/2012 Process Managers LLC Cincinnati District Office New Animal Drug/Adulterated 10/19/2012
05/18/2012 Advanced OrthoPro, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated 12/01/2015
05/18/2012 Seco Spice Ltd. Denver District Office CGMP Regulation For Food/Adulterated 10/16/2014
05/18/2012 Gramercy Fertility Services New York District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products 08/03/2012

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