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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
June 12, 2012 Set-N-Me-Free Aloe Vera Co. Seattle District Office New Drug/Labeling/False & Misleading Claims/Misbranded Not Issued *
June 12, 2012 F Care Systems USA Florida District Office Medical Device Reporting/Misbranded/Adulterated Not Issued *
June 12, 2012 International Specialty Supply Holding, Inc. Nashville District Office Food/Insanitary Conditions/Adulterated Not Issued *
June 11, 2012 Cal Valls Center for Food Safety and Applied Nutrition Misbranding/Labeling Violation of Acidified Foods August 24, 2012
June 11, 2012 Oertel Medical GmbH Center for Devices and Radiological Health Adulterated Device Not Issued *
June 11, 2012 Zhucheng Haotian Pharm Co., Ltd. Center for Drug Evaluation and Research Failure to Register and List Not Issued *
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 11, 2012 Beekley Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated 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 New Life Corporation Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 07, 2012 Oza Compound Products, LLC Detroit District Office CGMP for Dietary Supplement/Adulterated/Misbranded Not Issued *
June 05, 2012 Nevyas Eye Associates Center for Devices and Radiological Health Misbranding Not Issued *
June 05, 2012 Hijos De Carlos Albo S.L. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
June 05, 2012 CardioMEMS, Inc. Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *
June 05, 2012 Michigan Medical Innovations Detroit District Office CGMP/QSR/Medical Devices/Adulterated June 06, 2013
June 05, 2012 Koenen Dairy Inc Kansas City District Office Illegal Drug Residue Not Issued *
June 05, 2012 J.C. Maurer & Sons Minneapolis District Office Illegal Drug Residue July 09, 2012
June 04, 2012 lnnovision A/S Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated February 20, 2014
June 04, 2012 Van Ess Dairy LLC Kansas City District Office Illegal Drug Residue Not Issued *



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