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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
09/19/2013 Insight Pharmaceuticals Corporation Philadelphia District Office Labeling/False & Misleading Claims/Misbranded 09/22/2014
09/19/2013 Homeolab Inc. Center for Drug Evaluation and Research Labeling/False & Misleading Claims/Misbranded Not Issued *
09/19/2013 Topco Assoc Chicago District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
09/19/2013 Dolgencorp Inc New Orleans District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
09/18/2013 General Hearing Instruments Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/17/2013 Slate River Ranch LLC Dallas District Office Illegal Drug Residue Not Issued *
09/17/2013 Cheshire Valley Farms LLC New York District Office Illegal Drug Residue Not Issued *
09/17/2013 C.P.M. Contract Pharma GmbH & Co. KG Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) 01/14/2014
09/16/2013 Suzhou Armocon Technology Co. Ltd Center for Devices and Radiological Health Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded 11/25/2015
09/16/2013 Epflex Feinwerktechnik GmbH Center for Devices and Radiological Health Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded 07/16/2015
09/16/2013 Machia and Sons Dairy, LLC New England District Office Illegal Drug Residue Not Issued *
09/13/2013 Samuel A. Fisher Farm Philadelphia District Office Illegal Drug Residue 03/03/2014
09/13/2013 Bella Holsteins, Incorporated Denver District Office Illegal Drug Residue 09/11/2014
09/12/2013 Sirakoff, Dimitri Center for Drug Evaluation and Research Clinical Investigator Not Issued *
09/12/2013 Belter John Jr dba Ethan Allen Farm New England District Office Illegal Drug Residue Not Issued *
09/12/2013 Noon Hour Food Products, Inc. Chicago District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
09/12/2013 Flavour Makers Pty Ltd Center for Food Safety and Applied Nutrition Acidified Foods/Emergency Permit Control/Adulterated Not Issued *
09/12/2013 Portsmouth Chowder Co. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 05/08/2014
09/11/2013 Wholesale Depot Corp Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 11/25/2013
09/11/2013 Neuro Kinetics, Inc. Philadelphia District Office Premarket Approval/Misbranded/Adulterated 12/08/2015
09/10/2013 Virginia Center for Reproductive Medicine Baltimore District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
09/09/2013 Brower Enterprises Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 12/05/2014
09/09/2013 Agila Specialties Private Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
09/06/2013 82nd Avenue Tobacco & Pipe LTD Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 01/29/2014
09/06/2013 Hyline Orchards Minneapolis District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded 12/19/2014
09/06/2013 Pure Energy Products, Inc. Dallas District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
09/05/2013 Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded 03/31/2015
09/05/2013 www.cigsbymail.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 03/19/2014
09/05/2013 James T. Blue & Sons, Inc. Baltimore District Office Illegal Drug Residue Not Issued *
09/05/2013 Sigel Cattle Company, Inc. Cincinnati District Office Illegal Drug Residue Not Issued *
09/05/2013 Bakery Project Kansas City District Office CGMP Regulations for Food/Prepared, Packed or Held/Adulterated/Insanitary Not Issued *
09/03/2013 Nassim, Omid M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
08/30/2013 Dixie Health Inc Atlanta District Office New Drugs/Dietary Supplements/Misbranded Not Issued *
08/30/2013 Lucky Fortune Cookies, Inc. Baltimore District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated 03/24/2014
08/30/2013 Elder Grove Dairy Minneapolis District Office Illegal Drug Residue 10/28/2013
08/30/2013 FVS Holdings, Inc. dba. Green Valley Drugs San Francisco District Office New Drug/Misbranded Not Issued *
08/30/2013 Lloyd Inc. of Iowa Kansas City District Office Animal Drugs/Adulterated Not Issued *
08/29/2013 Y. S. Health Corp. Chicago District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Unapproved/Misbranded Not Issued *
08/29/2013 Sanquin Plasma Products Center for Biologics Evaluation and Research CGMP Deviations 09/15/2016
08/28/2013 Mason City Cold Storage Company Kansas City District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 07/07/2014
08/28/2013 Gatlinburlier, INC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 11/26/2013
08/27/2013 Rushing Waters Fisheries, LLC Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 04/28/2014
08/27/2013 Ching Jiang Fisheries Products, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
08/27/2013 Rocky Ford Pet Foods Denver District Office Cattle Materials Prohibited in Animal Food or Feed (CMPAF)/Adulterated 04/16/2014
08/27/2013 Weyand Fisheries, Inc. Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 10/28/2015
08/26/2013 St. Shine Optical Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
08/26/2013 Bio Focus Co. Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated 12/15/2015
08/22/2013 GumRunner, LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/False & Misleading Claims Not Issued *
08/22/2013 Crist Dairy Farm Cincinnati District Office Illegal Drug Residue Not Issued *
08/22/2013 Jabones Pardo S.A. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *

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