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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
10/29/2013 www.tobaccozoneplacentia.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 01/29/2015
10/29/2013 www.snusdirect.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/01/2015
10/29/2013 Browne Trading Co. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
10/28/2013 E R K Distributors LLC. Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
10/25/2013 Keyser Brothers Incorporated Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
10/25/2013 RZM Food Factory San Francisco District Office Insanitary Conditions/Adulterated Not Issued *
10/25/2013 Aptalis Pharma Us Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
10/25/2013 Taiyo Seafood, Inc Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
10/23/2013 Avacen Inc Los Angeles District Office Premarket Approval/Misbranded/Adulterated Not Issued *
10/23/2013 David Homan Cincinnati District Office Illegal Drug Residue Not Issued *
10/23/2013 www.tobaccocityfargo.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/04/2014
10/23/2013 www.deweyavesmokeshop.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 01/02/2014
10/23/2013 www.rockbottom-wholesale.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 11/25/2013
10/18/2013 R82 A/S Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
10/11/2013 Usp Labs Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated Not Issued *
10/09/2013 Virtual Sun, LLC New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
10/09/2013 www.serenawholesaler.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 12/06/2013
10/09/2013 www.usatobacco.biz Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 12/18/2013
10/04/2013 Allergy Laboratories, Inc. Office of Regulatory Affairs CGMP Deviations  Not Issued *
10/02/2013 Jason Martindale New York District Office Illegal Drug Residue Not Issued *
10/02/2013 Rocklan Farm New York District Office Illegal Drug Residue Not Issued *
10/02/2013 Lee K of NY Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
10/01/2013 Earl Wolfe Farms Inc Cincinnati District Office Illegal Drug Residue Not Issued *
10/01/2013 Poultry Products Company, Inc dba Poultry Products Northeast New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 04/13/2015
09/30/2013 Dennis J. Hurwitz, M.D. Center for Devices and Radiological Health Clinical Investigator - Human Trials Not Issued *
09/30/2013 King Systems Corp. Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/30/2013 El Campestre Distributor Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
09/27/2013 www.indo-cigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 12/04/2013
09/26/2013 Double W Dairy Denver District Office Illegal Drug Residue 09/29/2014
09/26/2013 Globus Medical, Inc. Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated 03/18/2014
09/25/2013 Standard Homeopathic Company, Inc. Los Angeles District Office False & Misleading Claims/Misbranded Not Issued *
09/25/2013 Jin Han International, Inc. (dba Pacific Foods Co.) Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
09/24/2013 Nephron Pharmaceuticals Corp. Florida District Office New Drug/Misbranded Not Issued *
09/24/2013 A&G Dairy Farms San Francisco District Office Illegal Drug Residue Not Issued *
09/24/2013 NIDEK Co., Ltd., Hamacho Plant Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated 05/26/2017
09/24/2013 Rich-Lou Farms Philadelphia District Office Illegal Drug Residue 02/24/2014
09/23/2013 American Aesthetics Medical Supply, Inc. Dallas District Office Medical Device Reporting/Misbranded Not Issued *
09/23/2013 Batrik Medical Mfg., Inc. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
09/23/2013 Haciendas Morales dba Granja Avicola Morales San Juan District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
09/20/2013 Medical Device Resource Corp San Francisco District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/20/2013 ConAgra Foods Inc New Orleans District Office Low Acid Canned Food Regulation/Adulterated/Insanitary Conditions 06/11/2014
09/20/2013 Capillus LLC Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/20/2013 Fomar Import/Export Inc. Dallas District Office Insanitary Conditions/Adulterated Not Issued *
09/20/2013 Bumblefish KC LLC Kansas City District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
09/19/2013 ANJI ZHENGBANG MEDICAL INSTRUMENT CO, LTD Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
09/19/2013 Herbalist and Alchemist, Inc. New Jersey District Office CGMP/Dietary Supplement/Adulterated 10/12/2016
09/19/2013 Medtech Products, Inc. New York District Office Labeling/False & Misleading Claims/Misbranded 11/06/2014
09/19/2013 Medtronic MiniMed Center for Devices and Radiological Health Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded 12/29/2014
09/19/2013 www.cheapcigsonline.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/19/2013 www.dynamicwd.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 11/07/2013

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