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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
September 19, 2013 www.cheapcigsonline.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
September 19, 2013 Medtech Products, Inc. New York District Office Labeling/False & Misleading Claims/Misbranded November 06, 2014
September 19, 2013 Insight Pharmaceuticals Corporation Philadelphia District Office Labeling/False & Misleading Claims/Misbranded September 22, 2014
September 19, 2013 Topco Assoc Chicago District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
September 18, 2013 General Hearing Instruments Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
September 17, 2013 C.P.M. Contract Pharma GmbH & Co. KG Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) January 14, 2014
September 17, 2013 Slate River Ranch LLC Dallas District Office Illegal Drug Residue Not Issued *
September 17, 2013 Cheshire Valley Farms LLC New York District Office Illegal Drug Residue Not Issued *
September 16, 2013 Epflex Feinwerktechnik GmbH Center for Devices and Radiological Health Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded July 16, 2015
September 16, 2013 Suzhou Armocon Technology Co. Ltd Center for Devices and Radiological Health Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded November 25, 2015
September 16, 2013 Machia and Sons Dairy, LLC New England District Office Illegal Drug Residue Not Issued *
September 13, 2013 Samuel A. Fisher Farm Philadelphia District Office Illegal Drug Residue March 03, 2014
September 13, 2013 Bella Holsteins, Incorporated Denver District Office Illegal Drug Residue September 11, 2014
September 12, 2013 Sirakoff, Dimitri Center for Drug Evaluation and Research Clinical Investigator Not Issued *
September 12, 2013 Belter John Jr dba Ethan Allen Farm New England District Office Illegal Drug Residue 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 12, 2013 Noon Hour Food Products, Inc. Chicago District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
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 December 08, 2015
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 December 05, 2014
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 Hyline Orchards Minneapolis District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded December 19, 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 05, 2013 www.cigsbymail.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded March 19, 2014
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 *
September 05, 2013 James T. Blue & Sons, Inc. Baltimore District Office Illegal Drug Residue Not Issued *
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 March 31, 2015
September 03, 2013 Nassim, Omid M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
August 30, 2013 Dixie Health Inc Atlanta District Office New Drugs/Dietary Supplements/Misbranded Not Issued *
August 30, 2013 FVS Holdings, Inc. dba. Green Valley Drugs San Francisco District Office New Drug/Misbranded Not Issued *
August 30, 2013 Elder Grove Dairy Minneapolis District Office Illegal Drug Residue October 28, 2013
August 30, 2013 Lucky Fortune Cookies, Inc. Baltimore District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated March 24, 2014
August 30, 2013 Lloyd Inc. of Iowa Kansas City District Office Animal Drugs/Adulterated Not Issued *
August 29, 2013 Y. S. Health Corp. Chicago District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Unapproved/Misbranded Not Issued *
August 29, 2013 Sanquin Plasma Products Center for Biologics Evaluation and Research CGMP Deviations September 15, 2016
August 28, 2013 Mason City Cold Storage Company Kansas City District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions July 07, 2014
August 28, 2013 Gatlinburlier, INC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 26, 2013
August 27, 2013 Weyand Fisheries, Inc. Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions October 28, 2015
August 27, 2013 Rushing Waters Fisheries, LLC Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions April 28, 2014
August 27, 2013 Rocky Ford Pet Foods Denver District Office Cattle Materials Prohibited in Animal Food or Feed (CMPAF)/Adulterated April 16, 2014
August 27, 2013 Ching Jiang Fisheries Products, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 26, 2013 St. Shine Optical Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
August 26, 2013 Bio Focus Co. Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated December 15, 2015
August 22, 2013 GumRunner, LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/False & Misleading Claims Not Issued *
August 22, 2013 John Brasil Dairy San Francisco District Office Illegal Drug Residue Not Issued *
August 22, 2013 Crist Dairy Farm Cincinnati District Office Illegal Drug Residue Not Issued *

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