Tuesday, February 18, 2020

Tuesday, February 18, 2020

FDA issued 13 warning letters in October


The U.S. Food and Drug Administration (FDA) issued 13 warning letters in October 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 issues.

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FDA Warning Letters Issued in October

Issue DateCompany NameIssuing OfficeSubject
Oct. 25, 2019E-Cigarette-Mart.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded
Oct. 24, 2019Eonsmoke LLCCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded
Oct. 17, 2019PETNET Solutions Inc.Division of Pharmaceutical Quality Operations ICGMP/Positron Emission Tomography (PET) Drugs / Adulterated
Oct. 11, 2019DSM Nutritional Products LLCDivision of Human and Animal Food Operations West IIIAdultered Animal Food / Misbranded
Oct. 10, 2019Rooted Apothecary LLCCenter for Drug Evaluation and ResearchUnapproved New Drugs / Misbranded / Cannabidiol (CBD) Products
Oct. 10, 2019Sofie Co., dba SofieDivision of Pharmaceutical Quality Operations IICGMP / Positron Emission Tomography (PET) Drugs / Adulterated
Oct. 9, 2019Pollman's Bake Shops Inc.Division of Human and Animal Food Operations East VCGMP Food / Prepared, Packed or Held Under Insanitary Conditions / Adulterated
Oct. 9, 2019Coral Pharmaceuticals LTDCenter for Drug Evaluation and ResearchCGMP / Finished Pharmaceuticals / Adulterated
Oct. 9, 2019Denterprise International Inc.Division of Medical Device and Radiological Health Operations CentralCGMP / QSR / Medical Devices / Adulterated
Oct. 8, 2019Torrent Pharmaceuticals LimitedCenter for Drug Evaluation and ResearchCGMP / Finished Pharmaceuticals / Adulterated
Oct. 4, 2019Herbal Doctor RemediesDivision of Pharmaceutical Quality Operations IVCGMP / Finished Pharmaceuticals / Adulterated
Oct. 3, 2019Glenmark Pharmaceuticals LimitedCenter for Drug Evaluation and ResearchCGMP / Finished Pharmaceuticals / Adulterated
Oct. 1, 2019The Skin Atelier, Inc. d.b.a. SkinprintDivision of Pharmaceutical Quality Operations ICGMP / Finished Pharmaceuticals / Adulterated
Source: U.S. Food and Drug Administration

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U.S. Food and Drug Administration (FDA)

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