Inspections, Compliance, Enforcement, and Criminal Investigations

2016 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
07/28/2016 Antioch Smoke Shop Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 03/21/2017
07/28/2016 Novastep Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
07/28/2016 Ameristar Casino Black Hawk Denver District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 10/19/2017
07/28/2016 Min Ny New York District Office New Drug/Labeling/Misbranded Not Issued *
07/28/2016 Jin Tzer Marine Products Co. Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 09/14/2017
07/27/2016 Tropic Fish Hawaii, LLC San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 03/30/2018
07/26/2016 PT Tritunggal Lintas Benua Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
07/26/2016 Concept Products Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
07/25/2016 Right Value Drug Stores, Inc. Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
07/25/2016 Pacific Export Corporation Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
07/22/2016 TPR Holding LLC New York District Office New Drug/Labeling/Misbranded Not Issued *
07/22/2016 J&E International Corp Seattle District Office Internet Marketing of Unapproved and Misbranded Drugs Not Issued *
07/22/2016 Hsu's Ginseng Enterprises, Inc Minneapolis District Office New Drug/Labeling/Misbranded 06/13/2017
07/22/2016 American Pharmacy of Illinois, Inc. dba Alwan's Pharmacy Chicago District Office Drug Product/Adulterated Not Issued *
07/22/2016 Peter Thomas Roth Labs, LLC New York District Office New Drug/Labeling/Misbranded 09/18/2017
07/22/2016 Celloxess LLC New Jersey District Office New Drug/Misbranded Not Issued *
07/22/2016 Lavian Ltd New York District Office New Drug/Labeling/Misbranded Not Issued *
07/22/2016 Kalman Health & Wellness, Inc. dba Essential Wellness Pharma Chicago District Office Drug Product/Adulterated Not Issued *
07/22/2016 New Horizon Nutraceuticals LLC Philadelphia District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
07/21/2016 La Bella Figura Chicago District Office New Drugs/Cosmetics Labeling and Marketing with Drug Claims Not Issued *
07/21/2016 Cold Turkey Juice Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Section 301(tt) Violation Not Issued *
07/21/2016 http://www.cig4u.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/20/2016 Finally Pure, LLC Seattle District Office Internet Marketing of Unapproved and Misbranded Drugs 01/17/2017
07/19/2016 Sircuit Skin Los Angeles District Office New Drug/Labeling/False & Misleading Claims 09/29/2016
07/19/2016 Sheryl Gibbs Philadelphia District Office New Drug/Labeling/False & Misleading Claims 08/09/2016
07/19/2016 Xiamen Origin Biotech Co. Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
07/19/2016 Mark Northcutt Kansas City District Office Illegal Drug Residue Animal Tissue/Adulterated 04/26/2018
07/19/2016 Oliverio's Italian Style Peppers, Inc. Baltimore District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded 04/10/2017
07/19/2016 Beyond Technology Corporation Nanchang Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
07/18/2016 Ageless Aesthetics Denver District Office New Drug/Labeling/False & Misleading Claims Not Issued *
07/18/2016 Michael Todd Florida District Office New Drugs/Cosmetics Labeling and Marketing with Drug Claims 04/05/2017
07/18/2016 Menscience Androceuticals Florida District Office New Drug/Labeling/Misbranded Not Issued *
07/15/2016 Aloe Farms, Inc Dallas District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded Not Issued *
07/15/2016 Oregon Potato Company Seattle District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
07/15/2016 Annemarie Gianni Skin Care LLC New England District Office New Drug/Labeling/Misbranded Not Issued *
07/15/2016 Karen Roche New England District Office New Drug/Misbranded Not Issued *
07/13/2016 DPI Specialty Foods Rocky Mountain, Inc. Denver District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 10/31/2017
07/12/2016 GenPak Solutions LLC Cincinnati District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
07/12/2016 TerraVare, Inc. New York District Office CGMP/Dietary Supplement/Misbranded Not Issued *
07/11/2016 Regional Radiology New Jersey District Office Mammography Quality Standards Not Issued *
07/08/2016 Health Innovations Pharmacy, Inc Atlanta District Office CGMP/Compounded Drugs/Misbranding 04/21/2008
07/07/2016 Keshodwala Foods Unit - II Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
07/05/2016 Brookfield Medical/Surgical Supply, Inc. New England District Office CGMP/Compounded Drugs/Misbranding Not Issued *
07/01/2016 BioGenyx-Basic Reset New Orleans District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
07/01/2016 Reser's Fine Foods Inc. Atlanta District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
06/30/2016 Morwai Dairy Denver District Office Illegal Drug Residue 07/25/2017
06/30/2016 Trimed Inc Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
06/30/2016 Mc-Cor, LLC San Juan District Office New Drug/Misbranded 11/22/2016
06/30/2016 SmithKline Beecham Limited Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
06/29/2016 Dreamland Trading Inc Minneapolis District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   03/10/2017

Page Last Updated: 02/18/2019
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