Inspections, Compliance, Enforcement, and Criminal Investigations

2017 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
08/17/2017 Distribuidora La Jugosita, Inc. San Juan District Office Juice/HACCP/Adulterated Not Issued *
08/17/2017 Vapor Rising, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/17/2017 Big Chief Vapor Products LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/16/2017 Eliquid UK Store Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/16/2017 Total Nutrition Inc New York District Office CGMP/Dietary Supplement/Adulterated/Misbranded 07/24/2018
08/16/2017 Sunshine Vape Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/16/2017 Krazie Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/16/2017 Flyin' Weasel E-Juice Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/16/2017 Cool Vape LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/16/2017 Klassik Vape, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/16/2017 Ecig.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/16/2017 E-Juice Plug Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/16/2017 KBF INC New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
08/16/2017 IP Eye Limited Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/15/2017 Adrian Mortimer Dallas District Office Illegal Drug Residue Not Issued *
08/15/2017 Years to Your Health, Inc. Dallas District Office Unapproved New Drugs/Misbranded Not Issued *
08/15/2017 Hetero Labs Limited Unit V Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
08/11/2017 Moon Valley Natural Products LLC Seattle District Office New Drug/Labeling/Misbranded Not Issued *
08/11/2017 Bicooya Cosmetics Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
08/10/2017 MS Fruit & Vegetable Co., LLC Cincinnati District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated 04/03/2018
08/10/2017 Skin 2 Spirit Baltimore District Office New Drug/Labeling/Misbranded Not Issued *
08/10/2017 C K Solutions, Inc. Denver District Office CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug Not Issued *
08/09/2017 Oregon Wild Berries, Inc. Seattle District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded Not Issued *
08/09/2017 Pharmacy Plus, Inc. dba Vital Care Compounder Dallas District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
08/08/2017 Wilbo S.A. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
08/07/2017 Hello Life, Inc Chicago District Office Labeling/Dietary Supplements/Promotional Claims False & Misleading/Misbranded Not Issued *
08/04/2017 Laveeza (nmi) Bhatti, M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
08/04/2017 MB Industria Cirurgica Ltda Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/03/2017 King of Pops Atlanta District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   01/12/2018
08/03/2017 ImprimisRx Pharmacy LLC New Jersey District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
08/03/2017 Ridley Block Operations Inc Cincinnati District Office Adultered Animal Food/Misbranded Not Issued *
08/02/2017 Maplerose Enterprises, LLC, dba Pencol Pharmacy Los Angeles District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
08/02/2017 Cellex-C International Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
08/02/2017 Homeolab USA Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Refused Inspection Not Issued *
08/02/2017 Coleman Peanut Company Baltimore District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
08/01/2017 Ballard Plaza Pharmacy I, Inc. Los Angeles District Office Compounding Pharmacy/Adulteration/Misbranding Not Issued *
08/01/2017 Foshan Flying Medical Products Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
08/01/2017 Armada Nutrition Cincinnati District Office CGMP/Dietary Supplement/Adulterated 03/13/2018
07/31/2017 Safe Way Ecig, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/31/2017 Broke Dick Juice Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/31/2017 SyncThink, Inc. Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *
07/31/2017 Vape Goddess LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/31/2017 Foggy Gorilla Vaping Company Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/31/2017 AspireCig LTD Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/31/2017 Green Leaf Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/31/2017 Freshvaping.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/28/2017 Skin Sciences Laboratory, Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
07/28/2017 Prodigy Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/28/2017 Vapor Alley Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/28/2017 Nuports Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *

Page Last Updated: 02/19/2019
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