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

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