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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2016 Warning Letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
12/28/2016 Regalo's Favorite of Hawaii Inc. Los Angeles District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
12/23/2016 Horizon Pharmaceuticals, Inc. Florida District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/23/2016 Wockhardt, Ltd. Center for Drug Evaluation and Research CGMP/APIs/Adulterated Not Issued *
12/22/2016 Northern Health Products Atlanta District Office Unapproved New Drugs/Misbranded Not Issued *
12/22/2016 Florida Key West, Inc. Florida District Office Juice/HACCP/Adulterated Not Issued *
12/22/2016 Tofu Yu, LLC San Francisco District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated 04/17/2017
12/22/2016 Rock Solid Nutrition, LLC Kansas City District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
12/21/2016 Sincerus Florida, LLC Florida District Office Unapproved New Drugs/Misbranded Not Issued *
12/19/2016 Samuel P. Hostetler (DBA) Hump-Back Dairys Kansas City District Office PHS Act/Unpasteurized Milk For Human Consumption Not Issued *
12/16/2016 Healthy Habits Los Angeles District Office New Drugs/Cosmetics Labeling and Marketing with Drug Claims Not Issued *
12/16/2016 ECIGRUS LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/16/2016 Vape USA Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/16/2016 www.tobaccolocker.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/16/2016 New Hampshire Cigars, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/16/2016 Premiumecigsmoking.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/15/2016 Nomax Inc Kansas City District Office Medical Devices/Adulterated/Quality System Regulation (QSR) Not Issued *
12/15/2016 Natura Bisse International S.A. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/15/2016 Intega Skin Sciences Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/15/2016 Derrek Olson, LLC Minneapolis District Office New Animal Drug/Adulterated 05/10/2017
12/15/2016 Aplicare, Inc. New England District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/15/2016 Pharmco Laboratories Inc. Florida District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
12/14/2016 PHD Marketing, INC. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/14/2016 EcigWEcig Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/13/2017
12/14/2016 JDL Engineering Associates Incorporated Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/14/2016 Electronic-cigz Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 03/13/2017
12/14/2016 Extreme Advertising Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/14/2016 eCigPros Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/14/2016 OK Smokey Ltd. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/04/2017
12/14/2016 Aro Tobacco Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/14/2016 Cigees Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/14/2016 Tiger Coco Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/14/2016 Elec-cigs.co.uk Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/14/2016 Cigars Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/14/2016 Shisha Pen Shop Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/13/2016 BnB Enterprise LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/13/2016 Vapor Junction Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/13/2016 Davidus Cigars, Ltd Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/11/2017
12/13/2016 Stix and Stones, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/05/2017
12/13/2016 Morris and Green Limited Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/11/2017
12/13/2016 Pure Smoke LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/05/2017
12/13/2016 Tripl3 eCigs and eGos Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/13/2016 Bull Smoke Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/18/2017
12/13/2016 Northridge Hospital Medical Cent Los Angeles District Office Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
12/13/2016 Auro Pharmacies, Inc. Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
12/12/2016 Smokin' Vapor, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/12/2016 Localads Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
12/12/2016 RiverMist Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/05/2017
12/12/2016 Double Tree Dairy Farm, LLC Denver District Office Illegal Drug Residue Not Issued *
12/12/2016 KommonCentz Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/13/2017
12/12/2016 http://www.altcig.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *

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