Inspections, Compliance, Enforcement, and Criminal Investigations

2018 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
10/31/2018 StemGenex Biologic Laboratories, LLC Center for Biologics Evaluation and Research Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
10/29/2018 Netcos Co., Ltd. Center for Drug Evaluation and Research Failure to Register and List Not Issued *
10/29/2018 United Exchange Corporation Center for Drug Evaluation and Research Failure to Register and List Not Issued *
10/26/2018 Greenpark Compounding Pharmacy Center for Drug Evaluation and Research Drug Product/Adulterated Not Issued *
10/19/2018 Gold Star Distrbution., Inc. Minneapolis District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
10/19/2018 Lakeview Dairy, LLC Minneapolis District Office Illegal Drug Residue Not Issued *
10/18/2018 Custom RX LLC dba Custom Rx Pharmacy and Wellness Concepts Detroit District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
10/17/2018 No More Fleas Please, Inc. Dallas District Office New Animal Drug/Adulterated Not Issued *
10/16/2018 Casa Pablo's Salsa LLC Seattle District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded Not Issued *
10/16/2018 Circle G Farm & Feed Lots Inc Chicago District Office Illegal Drug Residue Animal Tissue/Adulterated Not Issued *
10/11/2018 Vape International LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
10/11/2018 Bamboo LLC Atlanta District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
10/11/2018 HelloCig Electronic Technology Co., Ltd Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Section 301(tt) Violation Not Issued *
10/11/2018 Ozone Smoke, Inc Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
10/10/2018 Original Living Coconut, LLC Kansas City District Office Food Labeling/Misbranded Not Issued *
10/09/2018 MyRxAffiliate Program Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
10/09/2018 IceRx Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
10/09/2018 Farma Glow Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
10/09/2018 TeraPharm Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
10/09/2018 Discount Pharmacy Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
10/09/2018 Store Pills Network Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
10/09/2018 RxAff Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
10/05/2018 Farmers Ranchers Coop Assn Kansas City District Office CGMP/Animal Food/Medicated Feed/Adulterated Not Issued *
10/05/2018 Gilman Cooperative Creamery Association Minneapolis District Office CGMP/Medicated Feeds/Adulterated Not Issued *
10/03/2018 Hanlim Pharm Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
10/02/2018 Boule Medical AB Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
10/01/2018 Ignatius P. Godoy, M.D. Center for Biologics Evaluation and Research Bioresearch Monitoring Program/IRB   Not Issued *
09/27/2018 Elwood International, Inc. New York District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
09/26/2018 Vital Rx, Inc. dba Atlantic Pharmacy and Compounding Dallas District Office Drug Product/Adulterated Not Issued *
09/26/2018 120ml.co, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/26/2018 Clouds Vapors LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/24/2018 N-Molecular Inc. d.b.a. SOFIE New Jersey District Office CGMP/Positron Emission Tomography (PET) Drugs/Adulterated Not Issued *
09/24/2018 Auro Pharmacies Inc San Francisco District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
09/21/2018 Cardiomed Supplies, Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/21/2018 Vinill Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
09/21/2018 East Coast Vape Distribution Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/21/2018 Smoke and Vape DZ LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/21/2018 Good Vibes Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/21/2018 Empire Imports LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/21/2018 Paykoc Imports, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/21/2018 Cloud Dreams Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/21/2018 Oakshire Trading Co., LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/21/2018 Cloud 9 Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/21/2018 Apollo Future Tecnnology Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/19/2018 Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy San Francisco District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
09/18/2018 Rock Farm, LLC dba WholeFood Farmacy Cincinnati District Office Unapproved New Drugs/Misbranded Not Issued *
09/14/2018 Becton Dickinson Medical Systems Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/12/2018 E-Juice Vapor, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/12/2018 FireVapor.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/12/2018 Metro Vapors, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *

Page Last Updated: 11/18/2018
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