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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 16, 2013 Emrich Farms Philadelphia District Office Illegal Drug Residue December 06, 2013
April 16, 2013 Puget Sound Blood Center and Program Seattle District Office CGMPs for Blood & Blood Products/Finished Pharmaceuticals/Adulterated Not Issued *
April 15, 2013 Bubbas Fish House Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 16, 2014
April 15, 2013 South Side Seafood Inc Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions October 24, 2013
April 15, 2013 Irenda Corporation Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 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 12, 2013 www.indonesiastore.net, www.clovecigarette.org Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 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 *
April 11, 2013 Realm Labs, LLC Florida District Office Unapproved and Misbranded New Drugs Not Issued *
April 11, 2013 www.200discountsmokes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded March 11, 2014
April 11, 2013 Musculoskeletal Transplant Foundation New Jersey District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
April 10, 2013 Oy Ajat Ltd Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Not Issued *
April 10, 2013 CORPAK MedSystems, Inc. Chicago District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 10, 2013 www.directnetpartners.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
April 10, 2013 www.1cigarettesonline.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded March 18, 2014
April 09, 2013 Excel Medical Products, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 08, 2013 www.usatobaccoonline.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded May 01, 2013
April 08, 2013 Sterling Foods LLC San Francisco District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions February 27, 2014
April 08, 2013 Body Systems Inc. Florida District Office Unapproved and Misbranded New Drugs Not Issued *



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