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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
September 13, 2013 Bella Holsteins, Incorporated Denver District Office Illegal Drug Residue Not Issued *
September 13, 2013 Samuel A. Fisher Farm Philadelphia District Office Illegal Drug Residue March 03, 2014
September 12, 2013 Belter John Jr dba Ethan Allen Farm New England District Office Illegal Drug Residue Not Issued *
September 12, 2013 Dimitri Sirakoff Center for Drug Evaluation and Research Clinical Investigator Not Issued *
September 12, 2013 Noon Hour Food Products, Inc. Chicago District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
September 12, 2013 Flavour Makers Pty Ltd Center for Food Safety and Applied Nutrition Acidified Foods/Emergency Permit Control/Adulterated Not Issued *
September 12, 2013 Portsmouth Chowder Co. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions May 08, 2014
September 11, 2013 Wholesale Depot Corp Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 25, 2013
September 11, 2013 Neuro Kinetics, Inc. Philadelphia District Office Premarket Approval/Misbranded/Adulterated Not Issued *
September 10, 2013 Virginia Center for Reproductive Medicine Baltimore District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
September 09, 2013 Brower Enterprises Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
September 09, 2013 Agila Specialties Private Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
September 06, 2013 82nd Avenue Tobacco & Pipe LTD Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded January 29, 2014
September 06, 2013 Pure Energy Products, Inc. Dallas District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
September 06, 2013 Hyline Orchards Minneapolis District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded Not Issued *
September 05, 2013 www.cigsbymail.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded March 19, 2014
September 05, 2013 Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded Not Issued *
September 05, 2013 James T. Blue & Sons, Inc. Baltimore District Office Illegal Drug Residue Not Issued *
September 05, 2013 Bakery Project Kansas City District Office CGMP Regulations for Food/Prepared, Packed or Held/Adulterated/Insanitary Not Issued *
September 05, 2013 Sigel Cattle Company, Inc. Cincinnati District Office Illegal Drug Residue Not Issued *



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