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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
04/18/2013 Aurora Optics Company Inc New York District Office Medical Device Reporting/Misbranded Not Issued *
04/17/2013 Hillestad Pharmaceuticals USA, Inc. Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 06/12/2015
04/17/2013 A. C.' S Chinese Restaurant San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
04/16/2013 Emrich Farms Philadelphia District Office Illegal Drug Residue 12/06/2013
04/16/2013 Puget Sound Blood Center and Program Seattle District Office CGMPs for Blood & Blood Products/Finished Pharmaceuticals/Adulterated Not Issued *
04/16/2013 Bristol Seafood, Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 02/27/2014
04/15/2013 Bubbas Fish House Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 01/16/2014
04/15/2013 Irenda Corporation Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
04/15/2013 South Side Seafood Inc Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 10/24/2013
04/12/2013 www.indonesiastore.net, www.clovecigarette.org Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/12/2013 CONSERNOR Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
04/12/2013 4-Way Dairy, LLC Denver District Office Illegal Drug Residue 05/06/2014
04/11/2013 Alveologic LLC Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
04/11/2013 www.200discountsmokes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 03/11/2014
04/11/2013 Musculoskeletal Transplant Foundation New Jersey District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) 03/31/2015
04/11/2013 Realm Labs, LLC Florida District Office Unapproved and Misbranded New Drugs Not Issued *
04/10/2013 CORPAK MedSystems, Inc. Chicago District Office CGMP/QSR/Medical Devices/Adulterated 12/12/2014
04/10/2013 www.1cigarettesonline.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 03/18/2014
04/10/2013 www.directnetpartners.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/10/2013 Oy Ajat Ltd Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Not Issued *
04/09/2013 Excel Medical Products, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
04/08/2013 Body Systems Inc. Florida District Office Unapproved and Misbranded New Drugs Not Issued *
04/08/2013 www.cheapcigs24.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/08/2013 www.usatobaccoonline.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 05/01/2013
04/08/2013 Sterling Foods LLC San Francisco District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 02/27/2014
04/05/2013 The Glutathione Corporation New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
04/04/2013 www.cheap-cig.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/04/2013 www.tob-one.com/Fundacion Private Whois Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 03/20/2014
04/03/2013 Spine Smith Holdings, LLC Dallas District Office CGMP/QSR/Medical Devices/Adulterated 09/29/2015
04/03/2013 Heartland Gourmet, LLC Kansas City District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 11/08/2013
04/03/2013 Oak Grove Pork Inc Chicago District Office Illegal Drug Residue Not Issued *
04/02/2013 Cedar Ridge Farms Cincinnati District Office Illegal Drug Residue Not Issued *
04/02/2013 Joanne M. Tovar Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 03/11/2014
04/02/2013 www.cheap-smokes2.biz Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/11/2013
04/02/2013 Juve International, LLC Denver District Office New Drug/Labeling/False & Misleading Claims Not Issued *
04/02/2013 Natures Health Options LLC Florida District Office Unapproved and Misbranded New Drugs Not Issued *
04/01/2013 Kanebo Cosmetics Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
04/01/2013 Baxter Healthcare Corporation Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated/Misbranded Not Issued *
04/01/2013 Alimentos Prosalud, Sardimar Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
03/29/2013 KayPENTAX, A Division of PENTAX Medical Company New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
03/29/2013 Donlan Fish & Seafoods, Inc. Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 02/12/2014
03/29/2013 www.smokingtimes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
03/28/2013 Stewart Brothers, Inc. Seattle District Office Unapproved Food Additive/Nutrient and Health Claims/Misbranded Not Issued *
03/27/2013 Pranas Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated 06/15/2017
03/27/2013 Wyeth Lederle S.p.A Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 09/18/2017
03/27/2013 Mobilia Fruit Farms Inc. Philadelphia District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 01/14/2014
03/26/2013 Comercializadora Segura de Cartago S.S.R. S.A Center for Food Safety and Applied Nutrition CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
03/26/2013 Asociacion de Pequenos Agricultores Comalapenses de Producto Center for Food Safety and Applied Nutrition CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 05/28/2013
03/26/2013 Safecross First Aid Ltd Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
03/26/2013 THD SpA Center for Devices and Radiological Health Quality System Regulation/Medical Device Reporting/Adulterated Not Issued *

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