Sunday, October 20, 2019

Sunday, October 20, 2019

FDA issued 19 warning letters to companies in September


The U.S. Food and Drug Administration issued 19 warning letters in September 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 September

Issue DateCompany

Name

Issuing OfficeSubject
Sept. 30BitByBitCrypto Inc. d/b/a Vape CryptoCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded
Sept. 24Florida Import Export ServicesCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded
Sept. 23Natural Wonder Products CorpDivision of Pharmaceutical Quality Operations IVNew Animal Drug / Adulterated
Sept. 18Color Art, Inc. DBA Solid InkCenter for Food Safety and Applied NutritionCosmetics / Adulterated / Misbranded
Sept. 18Dynamic Color IncCenter for Food Safety and Applied NutritionCosmetics / Adulterated / Misbranded
Sept. 18Intenze Products Inc.Center for Food Safety and Applied NutritionCosmetics / Adulterated / Misbranded
Sept. 18Alternative LaboratoriesOffice of Human and Animal Food Operations East Division IVDietary Supplement / Adulterated
Sept. 13Galt Pharmaceuticals LLCOffice of Prescription Drug PromotionFalse & Misleading Claims / Misbranded
Sept. 12Dermameal Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals / Adulterated
Sept. 12Nutra Solutions USA, Inc.Division of Human and Animal Food Operations East ICGMP / Dietary Supplement / Adulterated / Misbranded
Sept. 10Lupin LimitedCenter for Drug Evaluation and ResearchCGMP / Active Pharmaceutical Ingredient (API) / Adulterated
Sept. 9Susan P. King-Harris, D.P.M.Center for Drug Evaluation and ResearchBioresearch Monitoring Program / IRB
Sept. 9JUUL Labs, Inc.Center for Tobacco ProductsModified Risk Tobacco Products
Sept. 6Meds4UCenter for Drug Evaluation and ResearchFinished Pharmaceuticals / Unapproved New Drug / Misbranded
Sept. 6DivyataCenter for Drug Evaluation and ResearchFinished Pharmaceuticals / Unapproved New Drug / Misbranded
Sept. 6JCM DropshipCenter for Drug Evaluation and ResearchFinished Pharmaceuticals / Unapproved New Drug / Misbranded
Sept. 6Euphoria Healthcare Pvt Ltd.Center for Drug Evaluation and ResearchFinished Pharmaceuticals / Unapproved New Drug / Misbranded
Sept. 6Crispy Delight Corp.Division of Human and Animal Food Operations East ICGMP / Food / Prepared, Packed or Held Under Insanitary Conditions / Adulterated
Sept. 6Sugarcreek Livestock Auction Inc.Division of Human and Animal Food Operations East V (HAFE5)CGMP / Medicated Feeds / Adulterated
Source: U.S. Food and Drug Administration

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U.S. Food and Drug Administration (FDA)

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