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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2012 Warning Letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
04/02/2012 Theta Brothers Sports Nutrition, Inc. New Jersey District Office CGMP Regulations For Dietary Supplements/Adulterated 06/23/2015
04/02/2012 NovaLung Gmbh Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 08/20/2013
03/30/2012 Vince & Sons Pasta Company Chicago District Office Seafood HACCP/Adulterated 03/14/2013
03/30/2012 LSL Industries, Inc. Chicago District Office Quality System Regulation/Adultered 11/27/2012
03/29/2012 Biomedical Research Institute of America d/b/a BioMed IRB Center for Biologics Evaluation and Research Institutional Review Board (IRB) 01/16/2013
03/29/2012 Spaletta Ranch San Francisco District Office Illegal Drug Residue Not Issued *
03/29/2012 American Fish & Seafood Co. San Francisco District Office Seafood HACCP/Adulterated Not Issued *
03/29/2012 Concept Asia Food Service LLC Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/28/2012 Health One Pharmaceuticals Inc Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
03/28/2012 Chinese Peptide Company Center for Drug Evaluation and Research Failure to Register and List 05/15/2012
03/27/2012 ThyssenKrupp Access Manufacturing, LLC Chicago District Office CGMP/QSR/Medical Devices/Adulterated 11/29/2012
03/27/2012 H & H Wholesale Services, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
03/27/2012 Christian Hospital Northeast-Northwest Center for Biologics Evaluation and Research Institutional Review Board (IRB) 05/07/2012
03/27/2012 Shanghai Shunlong Physical Therapy Equipment Co. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 11/19/2015
03/27/2012 Ogenix Corporation Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated 09/11/2012
03/27/2012 UNAM, Facultad De Estudios Superiores Cuautitlan Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
03/27/2012 River Ranch Fresh Foods, LLC San Francisco District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
03/26/2012 Kentron Health Care, Inc. New Orleans District Office Medical Device Reporting/Misbranded 10/18/2012
03/26/2012 Sullivan Lane Farm Philadelphia District Office Illegal Drug Residue 11/21/2013
03/26/2012 Korea Pharma Company Ltd Center for Drug Evaluation and Research Failure to Register and List Not Issued *
03/26/2012 SEI Pharmaceuticals, Inc. Florida District Office CGMP For Manufacturing, Packaging, Labeling, or Holding for Dietary Supplements/Adulterated Not Issued *
03/26/2012 Custom Seafood Services Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/23/2012 Meherrin Agricultural & Chemical Co. Atlanta District Office CGMP for Foods/Adulterated Not Issued *
03/23/2012 Plenus Group Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 03/14/2016
03/23/2012 cigarettesbuyer.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 05/24/2012
03/23/2012 Pacific Northwest Tofu, LLC Seattle District Office CGMP Food Labeling/False & Misleading/Misbranded Not Issued *
03/23/2012 Trafon Group, Inc. dba Star Meat San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated 04/19/2017
03/22/2012 Crystal Bay Seafoods, Inc. Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated 08/09/2013
03/22/2012 NuSil Technology LLC San Francisco District Office CGMP for Active Pharmaceutical Ingredient (API)/Adulterated 11/21/2012
03/22/2012 J.M. Smucker, LLC Minneapolis District Office Acidified Foods/Adulterated 04/11/2013
03/22/2012 High Performance Formulas, L.L.C. (HPF, L.L.C.) Philadelphia District Office New Drug/Labeling/Misbranded 04/24/2012
03/21/2012 Distribucion Y Representaciones Comerciales S.A. Center for Food Safety and Applied Nutrition CGMP for Foods/HACCP/Adulterated Not Issued *
03/21/2012 Lucero Medical, LLC Cincinnati District Office Device/Adulterated/Misbranded Not Issued *
03/20/2012 He Gao Plastic Factory Center for Devices and Radiological Health Adulterated Device/Misbranded 12/27/2016
03/20/2012 Loek Van Warmerdam Dairy San Francisco District Office Illegal Drug Residue Not Issued *
03/19/2012 Sugar Bakers, Inc. Baltimore District Office CGMP Regulation For Foods/Adulterated/Misbranded 08/12/2013
03/19/2012 Chung's and Son Company Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 01/10/2013
03/19/2012 Oriental Packing Co., Inc. Florida District Office CGMP Regulation for Foods/Adulterated Not Issued *
03/19/2012 Reproductive Medicine Institute IVF, LLC Florida District Office Deviations from/CFR/Regulations for Human Cells, Tissues & Cellular Products 11/07/2014
03/16/2012 Moniz Dairy Farm New England District Office Illegal Drug Residue Not Issued *
03/16/2012 Advanced Specialty Pharmacy dba Meds IV New Orleans District Office Total Parenteral Nutrition(TPN)Drug Products/Adulterated/Misbranded Not Issued *
03/15/2012 Topway Enterprises, Inc Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 09/06/2013
03/15/2012 Orlane S.A. Center for Drug Evaluation and Research Failure to Register and List 04/19/2012
03/15/2012 NeuroTrax Israel Ltd. Center for Devices and Radiological Health Premarket Approval/Medical Device/Adulterated Not Issued *
03/13/2012 IntelliCell Biosciences, Inc. Center for Biologics Evaluation and Research Current Good Manufacturing Practice(CGMP)/Current Good Tissue Practice(CGTP) Not Issued *
03/13/2012 A&M Farms San Francisco District Office Illegal Drug Residue Not Issued *
03/13/2012 Sushi Boy Inc Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/12/2012 Mysnus AB Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 05/21/2012
03/09/2012 Farma Quimia S.A. de C.V. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
03/09/2012 Pax-All Manufacturing Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 04/16/2015

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