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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 11, 2012 Brouillette Farm, Inc. New England District Office Illegal Drug Residue Not Issued *
June 11, 2012 Bausch & Lomb ELC SPL Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded Not Issued *
June 08, 2012 Endogastric Solutions, Inc. Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization Not Issued *
June 08, 2012 Michelle's Miracle, Inc. Detroit District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded May 03, 2013
June 07, 2012 Oza Compound Products, LLC Detroit District Office CGMP for Dietary Supplement/Adulterated/Misbranded Not Issued *
June 07, 2012 New Life Corporation Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 05, 2012 J.C. Maurer & Sons Minneapolis District Office Illegal Drug Residue July 09, 2012
June 05, 2012 Nevyas Eye Associates Center for Devices and Radiological Health Misbranding Not Issued *
June 05, 2012 Michigan Medical Innovations Detroit District Office CGMP/QSR/Medical Devices/Adulterated June 06, 2013
June 05, 2012 CardioMEMS, Inc. Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization Not Issued *
June 05, 2012 Koenen Dairy Inc Kansas City District Office Illegal Drug Residue Not Issued *
June 05, 2012 Hijos De Carlos Albo S.L. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
June 04, 2012 Van Ess Dairy LLC Kansas City District Office Illegal Drug Residue Not Issued *
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 Houser, Elizabeth E. 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
May 24, 2012 Good Herbs, Inc. Detroit District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
May 24, 2012 De Groot Sheep Inc Kansas City District Office Illegal Drug Residue July 31, 2013
May 24, 2012 Northwest Pharmacy Center for Drug Evaluation and Research Unapproved New Drug-Misbranded June 28, 2012
May 24, 2012 Faci S.P.A. Center for Drug Evaluation and Research Failure to Register and List June 14, 2012
May 24, 2012 FairPrice Tobacco, Inc d/b/a www. RYOCigarette.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded August 13, 2012
May 23, 2012 RockStar, Inc. DBA Livingston Chocolate Company New Orleans District Office Unapproved Food Additive/Adulterated Not Issued *
May 23, 2012 Tango3 LLC Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 22, 2012 Ernest P. Shoup Farm Cincinnati District Office Illegal Drug Residue Not Issued *
May 22, 2012 Mc-NEIL-PPC, Inc. New Jersey District Office Adulterated Device May 22, 2014
May 22, 2012 Malcolm, Matthew PhD., OTR Center for Devices and Radiological Health Sponsor-Investigator Not Issued *
May 21, 2012 Nicho Produce Co., Inc. Dallas District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
May 21, 2012 Smith Family Frosted Foods LLC Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 18, 2012 Process Managers LLC Cincinnati District Office New Animal Drug/Adulterated October 19, 2012
May 18, 2012 Advanced OrthoPro, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated December 01, 2015
May 18, 2012 Seco Spice Ltd. Denver District Office CGMP Regulation For Food/Adulterated October 16, 2014
May 18, 2012 Gramercy Fertility Services New York District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products August 03, 2012
May 18, 2012 Arrowhead DE LLC, DBA Arrowhead Medical Device Technologies New Orleans District Office CGMP/QSR/Medical Devices/Adulterated April 16, 2013

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