Inspections, Compliance, Enforcement, and Criminal Investigations

2015 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
10/19/2015 Caney Distributors Inc San Juan District Office Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
10/19/2015 James A. Gilligan New York District Office Illegal Drug Residue Not Issued *
10/19/2015 River Valley Dairy New York District Office Illegal Drug Residue Not Issued *
10/16/2015 Cardionics SA Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
10/16/2015 Sound Healing Arts, PC DBA Grounds for Tea LLC Seattle District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
10/15/2015 Seeds of Light Enterprises Florida District Office Unapproved New Drugs/Misbranded Not Issued *
10/15/2015 www.discountforcigs.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
10/15/2015 http://www.all-discount-smokes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
10/13/2015 Fehling Instruments GmbH & Co. KG Center for Drug Evaluation and Research CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
10/08/2015 77 Elektronika Kft. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
10/08/2015 Van Kooten Dairy Dallas District Office Illegal Drug Residue Not Issued *
10/08/2015 www.cheapcigarettesusa.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
10/07/2015 NY Smoke Scene Corp. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
10/07/2015 Pat's Exotic Beverages, Inc. New York District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
10/05/2015 Ribon Company, Ltd. Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded 11/02/2016
10/05/2015 Gentell Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated 03/16/2017
10/02/2015 Hubei Weikang Protective Products Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded 12/27/2016
10/02/2015 Gourmet Classic Salads, Inc. Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
10/01/2015 Panoramic Rental Corp. Detroit District Office Medical Device Reporting/Misbranded Not Issued *
10/01/2015 New Zealand Seafood Marketing Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 02/29/2016
10/01/2015 La Casa del Habano (Hava Havana) Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 10/30/2015
10/01/2015 MPH Nutrition LLC Chicago District Office CGMP/Dietary Supplement/Adulterated/Therapeutic Claims Not Issued *
09/30/2015 Banyan Medical, LLC New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/30/2015 Argo Medical Technologies Inc. Center for Devices and Radiological Health Device/Misbranded Not Issued *
09/30/2015 Merge Healthcare, Inc. Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated 09/27/2016
09/30/2015 Lusys Laboratories, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/30/2015 Paks Clothiers (dba) Aqua Pure Drinking Water Los Angeles District Office Food/Bottled Water/CGMP/Prepared, Packed, or Held Under Insanitary Conditions Not Issued *
09/30/2015 St. Jude Medical (CardioMEMS) Atlanta District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/30/2015 GeoTec, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/29/2015 Hieber's Pharmacy Philadelphia District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
09/29/2015 Hieber's Pharmacy Philadelphia District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
09/28/2015 Kirk Farris Dallas District Office Illegal Drug Residue Not Issued *
09/28/2015 Unimark Remedies Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
09/28/2015 Byron Kramer, Inc. Denver District Office Illegal Drug Residue 10/05/2016
09/25/2015 Aros Surgical Instruments Corporation Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated 10/27/2015
09/25/2015 Jerry Ethington Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
09/24/2015 Medsource, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated 05/17/2016
09/24/2015 New Dawn Nutrition, Inc. Kansas City District Office CGMP/Dietary Supplement/Misbranded/Adulterated Not Issued *
09/22/2015 Toque Snuff Limited Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 02/10/2016
09/21/2015 Genesis Biosystems, Inc Dallas District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device Not Issued *
09/21/2015 East Oceanic International Co Ltd New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
09/21/2015 TruVision Health LLC Center for Food Safety and Applied Nutrition DMBA/Labeling/Dietary Supplements/Adulterated Not Issued *
09/18/2015 Double A Dairy Seattle District Office Illegal Drug Residue Not Issued *
09/17/2015 Life Support Development Ltd Cincinnati District Office Unapproved New Drugs/Misbranded Not Issued *
09/17/2015 Ruby's Quail Farm Dallas District Office Acidified Foods/Emergency Permit Control/Adulterated Not Issued *
09/17/2015 Red Mill Farms LLC Philadelphia District Office Unapproved New Drugs/Misbranded Not Issued *
09/17/2015 International Medical Development Corporation Denver District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *
09/16/2015 Ferrosan Medical Devices A/s Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded 11/09/2015
09/16/2015 SwedLex / Swedsnus Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/16/2015 Richard W. Weaver New York District Office Illegal Drug Residue Not Issued *

Page Last Updated: 03/20/2019
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