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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
March 23, 2012 Plenus Group Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 22, 2012 High Performance Formulas, L.L.C. (HPF, L.L.C.) Philadelphia District Office New Drug/Labeling/Misbranded April 24, 2012
March 22, 2012 J.M. Smucker, LLC Minneapolis District Office Acidified Foods/Adulterated April 11, 2013
March 22, 2012 NuSil Technology LLC San Francisco District Office CGMP for Active Pharmaceutical Ingredient (API)/Adulterated November 21, 2012
March 22, 2012 Crystal Bay Seafoods, Inc. Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated August 09, 2013
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 He Gao Plastic Factory Center for Devices and Radiological Health Adulterated Device/Misbranding Not Issued *
March 20, 2012 Loek Van Warmerdam Dairy San Francisco District Office Extralabel Drug Use in Animals/Adulterated Not Issued *
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 Oriental Packing Co., Inc. Florida District Office CGMP Regulation for Foods/Adulterated Not Issued *
March 19, 2012 Reproductive Medicine Institute IVF, LLC Florida District Office Deviations from/CFR/Regulations for Human Cells, Tissues & Cellular Products Not Issued *
March 19, 2012 Sugar Bakers, Inc. Baltimore District Office CGMP Regulation For Foods/Adulterated/Misbranded August 12, 2013
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 Orlane S.A. Center for Drug Evaluation and Research Failure to Register and List April 19, 2012
March 15, 2012 Topway Enterprises, Inc Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions September 06, 2013
March 15, 2012 NeuroTrax Israel Ltd. Center for Devices and Radiological Health Premarket Approval/Medical Device/Adulterated Not Issued *
March 13, 2012 Sushi Boy Inc Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 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 *



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