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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2012 Warning Letters

Posted on June 26, 2012

Letter Issue Date Company Name Issuing Office Subject Close Out Date
June 14, 2012 Covidien LP New England District Office CGMP/QSR/Medical Devices/Adulterated April 21, 2013
June 14, 2012 American· Optisurgical Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 14, 2012 Metro Produce Distributors, Inc. Minneapolis District Office Juice/HACCP/Adulterated Not Issued *
June 14, 2012 Pinook-USA Florida District Office Medical Device/Adulterated/Misbranded Not Issued *
June 14, 2012 Acclarent, Inc. San Francisco District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 13, 2012 Compania Internacional de Comercio, S.A. de C.V. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
June 12, 2012 King Ransom Farm LLC New York District Office Illegal Drug Residue Not Issued *
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 Bausch & Lomb ELC SPL Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded 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 Beekley Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 11, 2012 Brouillette Farm, Inc. New England District Office Illegal Drug Residue Not Issued *
June 11, 2012 Oertel Medical GmbH Center for Devices and Radiological Health Adulterated Device Not Issued *
June 11, 2012 Cal Valls Center for Food Safety and Applied Nutrition Misbranding/Labeling Violation of Acidified Foods August 24, 2012
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 Hijos De Carlos Albo S.L. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *


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