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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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2013 Warning Letters

Posted on May 07, 2013

Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 26, 2013 Pristine Bay LLC dba Vianda Cincinnati District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
April 26, 2013 ACell, Inc Baltimore District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 26, 2013 Zeinstra Farms, LLC Detroit District Office Illegal Drug Residue Not Issued *
April 25, 2013 CMI Cosmetic Manufacturers Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
April 25, 2013 Shippert Medical Technologies Denver District Office CGMP/QSR/Medical Devices/Adulterated 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 24, 2013 Glucorell, Inc. / Anafit, Inc. Florida District Office Unapproved and Misbranded New Drugs Not Issued *
April 24, 2013 Europharma Co., Inc. Minneapolis District Office New Drug/Labeling/False & Misleading Claims 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 Glottal Enterprises Inc. New York District Office Medical Device Reporting/Misbranded Not Issued *
April 23, 2013 www.cheapcigarette4you.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
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 Natus Europe GmbH Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 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 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 Sushi USA Inc. Baltimore District Office Seafood HACCP/CGMP for Foods/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 Not Issued *
April 18, 2013 Biofournil Of America Inc. Seattle District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
April 17, 2013 Hillestad Pharmaceuticals USA, Inc. Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *


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