Inspections, Compliance, Enforcement, and Criminal Investigations

2017 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
05/08/2017 Harbor Marine Product Inc Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
05/08/2017 International Medsurg Connection, Inc. Chicago District Office CGMP/QSR/Medical Devices/Adulterated 10/16/2018
05/08/2017 Nurse Assist, Inc Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
05/05/2017 Vidco, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
05/05/2017 Fabrica de Conservas A Poveira, S.A. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
05/05/2017 Barnier Production Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated 09/15/2017
05/04/2017 Rainbow Gold Products Inc New Orleans District Office Unapproved New Drugs/Misbranded Not Issued *
05/03/2017 MS Bionic Los Angeles District Office Unapproved New Drugs/Misbranded Not Issued *
05/03/2017 Pharmaceutic Labs, LLC. New York District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
05/02/2017 Genus Medical Technologies Kansas City District Office Unapproved New Drugs/Misbranded Not Issued *
05/01/2017 Nature's Vision, Inc Detroit District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
05/01/2017 Thor Inc. Denver District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
05/01/2017 Oxford Performance Materials, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
04/28/2017 Shriver III, Victor L., a.k.a. Chip Chicago District Office Illegal Drug Residue Not Issued *
04/28/2017 Vikshara Trading & Investments Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
04/28/2017 http://www.snuffstore.co.uk Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/27/2017 LegendGadget Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/27/2017 Hardcore Vapers, B.V Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/27/2017 Rad Trading Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/27/2017 Big Boss Cigars Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/27/2017 Vapor Palace Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/27/2017 Vapor-riffic, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/27/2017 http://www.pharmacig.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/27/2017 The Lord of the Cigar Corporation Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/27/2017 Wholesale-Eliquid.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/27/2017 406 Cigars Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/26/2017 Mahard Egg Farm, Inc. (Boogie Hill) Dallas District Office Food/Egg/Prepared Packed or Held Under Insanitary Conditions/Adulterated 12/22/2017
04/26/2017 Anatox Inc. Center for Food Safety and Applied Nutrition CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
04/26/2017 B & I Overseas Trading Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
04/25/2017 Northern Fish Products, Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 02/28/2018
04/25/2017 Unetixs Vascular Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
04/25/2017 Rosemark Bakery, Inc. Minneapolis District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
04/24/2017 Qinhuangdao Zizhu Pharmaceutical, Co. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
04/21/2017 Lonza Walkersville, Inc. Baltimore District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
04/21/2017 Criticare Technologies Inc New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
04/20/2017 Sal Pharma Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded Not Issued *
04/20/2017 Organ Recovery Systems, Inc. Chicago District Office CGMP/QSR/Medical Devices/Adulterated 11/28/2018
04/20/2017 Adolfo Kaplan Center for Drug Evaluation and Research Clinical Investigator Not Issued *
04/20/2017 Naturecom Inc. Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
04/20/2017 Huron Pharmaceuticals, Inc. Detroit District Office CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
04/20/2017 Montana Emu Ranch Company Inc Seattle District Office Unapproved New Animal Drug/Adultered/Misbranded/Misleading 01/31/2018
04/19/2017 Exact-Rx Inc Center for Drug Evaluation and Research Failure to Register and List 04/27/2017
04/19/2017 Tobin's Royal Stag, Inc. dba Tobin Farms Velvet Antler New England District Office Unapproved New Drugs/Misbranded Not Issued *
04/18/2017 Stoney Ridge Farm, LLC Seattle District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 04/02/2018
04/17/2017 Aie Pharmaceuticals Inc Los Angeles District Office Unapproved New Drugs/Misbranded Not Issued *
04/17/2017 DoctorVicks.com New York District Office Unapproved New Drugs/Misbranded 02/02/2018
04/17/2017 Lifevantage Corp Denver District Office Unapproved New Drugs/Misbranded Not Issued *
04/17/2017 Sunstone, Inc. Denver District Office Unapproved New Drugs/Misbranded Not Issued *
04/17/2017 Nature's Treasures Los Angeles District Office Unapproved New Drugs/Misbranded Not Issued *
04/17/2017 Healing Within Products & Services, Inc. San Francisco District Office Unapproved New Drugs/Misbranded Not Issued *

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