Inspections, Compliance, Enforcement, and Criminal Investigations

2019 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
04/12/2019 Abaxis Inc Los Angeles District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *
04/11/2019 Total Body Nutrition Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated Not Issued *
04/10/2019 Empire Distributors, Inc. Detroit District Office New Drug/Labeling/Misbranded Not Issued *
04/10/2019 IQ Formulations, LLC Center for Food Safety and Applied Nutrition Dietary Supplement/Misbranded Not Issued *
04/10/2019 Atomixx Center for Food Safety and Applied Nutrition Dietary Supplement/Misbranded Not Issued *
04/10/2019 eflow Nutrition LLC Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated Not Issued *
04/10/2019 Iron Brothers Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated Not Issued *
04/10/2019 NeuroScience Solutions, Inc. dba NeuroScience Center for Food Safety and Applied Nutrition Dietary Supplement/Misbranded Not Issued *
04/10/2019 Evol Nutrition Associates, Inc. d/b/a Red Dawn Energy Center for Food Safety and Applied Nutrition Dietary Supplement/Misbranded Not Issued *
04/10/2019 DC Laboratories Inc., d/b/a Dynamic Creations Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/10/2019 Down to Earth Solutions, LLC Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated Not Issued *
04/10/2019 Hi Tech Pharmaceuticals Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated Not Issued *
04/10/2019 Forbiddenlabz Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated Not Issued *
04/10/2019 Line One Nutrition, Inc Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated Not Issued *
04/04/2019 Undisputed Worldwide Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/False & Misleading Claims/Misbranded Not Issued *
04/04/2019 Inova Genomics Laboratory Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
04/04/2019 Luen Fook Medicine Sdn. Bhd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
04/04/2019 EZ Fumes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/False & Misleading Claims/Misbranded Not Issued *
03/29/2019 Lotus Vaping Technology LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
03/29/2019 https://www.vapevandal.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
03/29/2019 Cord for Life, Inc. Center for Biologics Evaluation and Research Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
03/28/2019 RIJ Pharmaceutical LLC New Jersey District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
03/28/2019 PotNetwork Holdings, Inc. Center for Food Safety and Applied Nutrition New Drug/Misbranded Not Issued *
03/28/2019 Advanced Spine and Pain, LLC (d/b/a Relievus) Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
03/28/2019 Nutra Pure LLC Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
03/27/2019 Thedonrx.net Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
03/27/2019 Catnip Cocktail Los Angeles District Office New Animal Drug/Adulterated Not Issued *
03/27/2019 Azmedicinalshop.com Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
03/26/2019 ImprimisRx CA, Inc., dba ImprimisRx Los Angeles District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
03/21/2019 B. Jain Pharmaceuticals Private Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
03/20/2019 Infusion Partners, LLC Detroit District Office Drug Product/Adulterated Not Issued *
03/20/2019 Apollo Care Detroit District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
03/20/2019 Tec Laboratories Inc Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
03/20/2019 King Bio Inc. Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
03/20/2019 Red Mountain Inc Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
03/18/2019 Mentor Worldwide LLC & Acclarent Center for Devices and Radiological Health Premarket Approval/Adulterated Not Issued *
03/18/2019 Sientra Inc Center for Devices and Radiological Health Premarket Approval/Adulterated Not Issued *
03/18/2019 Dong Yuan Technology Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
03/15/2019 D’Andrea Foods Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/14/2019 Mariposa Labs, LLC Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
03/14/2019 Marukyo Co., Ltd. Center for Food Safety and Applied Nutrition Acidified Foods/Emergency Permit Control/Adulterated/Misbranded Not Issued *
03/13/2019 One Way Drug LLC dba Partell Specialty Pharmacy Los Angeles District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
03/12/2019 Uustar Corporation dba Daily Vita, LLC Atlanta District Office Unapproved New Drugs/Misbranded Not Issued *
03/11/2019 Merchants Market St. Croix LLC San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/11/2019 Nutra Pharma Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
03/08/2019 Aidaccess.org Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
03/08/2019 Rablon Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
03/07/2019 Flea Assassin, LLC Dallas District Office New Animal Drug/Adulterated Not Issued *
03/06/2019 INDY E CIGS LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
03/06/2019 TEI Biosciences, Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *

Page Last Updated: 04/23/2019
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