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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 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 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 19, 2013 Natus Europe GmbH Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 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 *
April 17, 2013 A. C.' S Chinese Restaurant San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
April 16, 2013 Puget Sound Blood Center and Program Seattle District Office CGMPs for Blood & Blood Products/Finished Pharmaceuticals/Adulterated Not Issued *
April 16, 2013 Emrich Farms Philadelphia District Office Illegal Drug Residue Not Issued *
April 16, 2013 Bristol Seafood, Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
April 15, 2013 South Side Seafood Inc Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
April 12, 2013 www.indonesiastore.net, www.clovecigarette.org Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
April 12, 2013 CONSERNOR Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
April 12, 2013 4-Way Dairy, LLC Denver District Office Illegal Drug Residue Not Issued *
April 11, 2013 Musculoskeletal Transplant Foundation New Jersey District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
April 11, 2013 Alveologic LLC Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *


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