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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 25, 2013 CooperSurgical, Inc. D.B.A. Lone Star Medical Products Dallas District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
April 25, 2013 Quantum Herbal Products New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
April 24, 2013 Europharma Co., Inc. Minneapolis District Office New Drug/Labeling/False & Misleading Claims Not Issued *
April 24, 2013 Glucorell, Inc. / Anafit, Inc. Florida District Office Unapproved and Misbranded New Drugs Not Issued *
April 24, 2013 Olympia Womens Health Seattle District Office Deviations from CFR Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
April 23, 2013 Glottal Enterprises Inc. New York District Office Medical Device Reporting/Misbranded Not Issued *
April 23, 2013 Care Diagnostica GmbH Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
April 23, 2013 www.cheapcigarette4you.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded June 12, 2013
April 23, 2013 A & M Bakery, Inc. Baltimore District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
April 19, 2013 Kato Suisan Co. Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
April 19, 2013 Natus Europe GmbH Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded January 13, 2014
April 19, 2013 Sushi USA Inc. Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
April 19, 2013 MEDICAMAT S.A. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
April 19, 2013 Kosher Foods Unlimited, Inc. dba got kosher ? Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
April 18, 2013 Aurora Optics Company Inc New York District Office Medical Device Reporting/Misbranded Not Issued *
April 18, 2013 COVI S.A.S Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated May 07, 2013
April 18, 2013 Biofournil Of America Inc. Seattle District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
April 18, 2013 Blackstar Fish Co Inc Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
April 18, 2013 Freskeeto Frozen Foods Inc New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions October 07, 2013
April 17, 2013 A. C.' S Chinese Restaurant San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *



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