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 Date | Company Name | Issuing Office | Subject |
| Oct. 25, 2019 | E-Cigarette-Mart.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded |
| Oct. 24, 2019 | Eonsmoke LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded |
| Oct. 17, 2019 | PETNET Solutions Inc. | Division of Pharmaceutical Quality Operations I | CGMP/Positron Emission Tomography (PET) Drugs / Adulterated |
| Oct. 11, 2019 | DSM Nutritional Products LLC | Division of Human and Animal Food Operations West III | Adultered Animal Food / Misbranded |
| Oct. 10, 2019 | Rooted Apothecary LLC | Center for Drug Evaluation and Research | Unapproved New Drugs / Misbranded / Cannabidiol (CBD) Products |
| Oct. 10, 2019 | Sofie Co., dba Sofie | Division of Pharmaceutical Quality Operations II | CGMP / Positron Emission Tomography (PET) Drugs / Adulterated |
| Oct. 9, 2019 | Pollman's Bake Shops Inc. | Division of Human and Animal Food Operations East V | CGMP Food / Prepared, Packed or Held Under Insanitary Conditions / Adulterated |
| Oct. 9, 2019 | Coral Pharmaceuticals LTD | Center for Drug Evaluation and Research | CGMP / Finished Pharmaceuticals / Adulterated |
| Oct. 9, 2019 | Denterprise International Inc. | Division of Medical Device and Radiological Health Operations Central | CGMP / QSR / Medical Devices / Adulterated |
| Oct. 8, 2019 | Torrent Pharmaceuticals Limited | Center for Drug Evaluation and Research | CGMP / Finished Pharmaceuticals / Adulterated |
| Oct. 4, 2019 | Herbal Doctor Remedies | Division of Pharmaceutical Quality Operations IV | CGMP / Finished Pharmaceuticals / Adulterated |
| Oct. 3, 2019 | Glenmark Pharmaceuticals Limited | Center for Drug Evaluation and Research | CGMP / Finished Pharmaceuticals / Adulterated |
| Oct. 1, 2019 | The Skin Atelier, Inc. d.b.a. Skinprint | Division of Pharmaceutical Quality Operations I | CGMP / Finished Pharmaceuticals / Adulterated |
