Tuesday, February 18, 2020

Tuesday, February 18, 2020

FDA issued 14 warning letters to companies in July


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The U.S. Food and Drug Administration issued 14 warning letters in July that were sent to manufacturers and other companies found to have violated FDA regulations.

“The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use,” the FDA reports.

Such letters, which can be sent to product manufacturers, tobacco retailers, drug marketers and advertisers, direct the company to comply with the designated regulations and provide the FDA with a timeline to fix the problems.

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FDA Warning Letters Issued in July

Issue DateCompany NameIssuing OfficeSubject
July 22Curaleaf Inc.Center for Drug Evaluation and ResearchUnapproved New Drugs/ Misbranded/ Cannabidiol (CBD) Products
July 17Nor-Scot Trading LimitedCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/ Adulterated/ Misbranded
July 16Indoco Remedies LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/ Adulterated
July 16AB Seafood Trading Inc.Division of Human and Animal Food Operations East ISeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
July 15Port Clyde Fresh Catch Inc.Division of Human and Animal Food Operations East ISeafood HACCP/CGMP for Foods/ Adulterated/ Insanitary Conditions
July 12EFF Marketing LTD d/b/a CigaraCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/ Adulterated/ Misbranded
July 12Origin VapeCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/ Adulterated/ Misbranded
July 12Monkey VaporsCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/ Adulterated/ Misbranded
July 11American Sales Company Inc.Center for Drug Evaluation and ResearchFailure to Comply with Drug Listing Requirements
July 9Ceba-Tek Inc.Office of Human and Animal Food Operations Division IV EastCGMP/ Dietary Supplement/ Adulterated/ Misbranded
July 2High Chemical Company, Division of National Generic DistributorsDivision of Pharmaceutical Quality Operations ICGMP/ Active Pharmaceutical Ingredient (API)/ Adulterated
July 1Stratus BioSystems LLCCenter for Biologics Evaluation and ResearchDeviations/ CFR/ Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
July 1Strides Pharma Science LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated
July 1Virginia Center for Reproductive MedicineDivision of Biological Products Operations IDeviations/ CFR/ Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Source: U.S. Food and Drug Administration

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U.S. Food and Drug Administration (FDA)

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