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 Date | Company
Name | Issuing Office | Subject |
| Sept. 30 | BitByBitCrypto Inc. d/b/a Vape Crypto | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded |
| Sept. 24 | Florida Import Export Services | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded |
| Sept. 23 | Natural Wonder Products Corp | Division of Pharmaceutical Quality Operations IV | New Animal Drug / Adulterated |
| Sept. 18 | Color Art, Inc. DBA Solid Ink | Center for Food Safety and Applied Nutrition | Cosmetics / Adulterated / Misbranded |
| Sept. 18 | Dynamic Color Inc | Center for Food Safety and Applied Nutrition | Cosmetics / Adulterated / Misbranded |
| Sept. 18 | Intenze Products Inc. | Center for Food Safety and Applied Nutrition | Cosmetics / Adulterated / Misbranded |
| Sept. 18 | Alternative Laboratories | Office of Human and Animal Food Operations East Division IV | Dietary Supplement / Adulterated |
| Sept. 13 | Galt Pharmaceuticals LLC | Office of Prescription Drug Promotion | False & Misleading Claims / Misbranded |
| Sept. 12 | Dermameal Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals / Adulterated |
| Sept. 12 | Nutra Solutions USA, Inc. | Division of Human and Animal Food Operations East I | CGMP / Dietary Supplement / Adulterated / Misbranded |
| Sept. 10 | Lupin Limited | Center for Drug Evaluation and Research | CGMP / Active Pharmaceutical Ingredient (API) / Adulterated |
| Sept. 9 | Susan P. King-Harris, D.P.M. | Center for Drug Evaluation and Research | Bioresearch Monitoring Program / IRB |
| Sept. 9 | JUUL Labs, Inc. | Center for Tobacco Products | Modified Risk Tobacco Products |
| Sept. 6 | Meds4U | Center for Drug Evaluation and Research | Finished Pharmaceuticals / Unapproved New Drug / Misbranded |
| Sept. 6 | Divyata | Center for Drug Evaluation and Research | Finished Pharmaceuticals / Unapproved New Drug / Misbranded |
| Sept. 6 | JCM Dropship | Center for Drug Evaluation and Research | Finished Pharmaceuticals / Unapproved New Drug / Misbranded |
| Sept. 6 | Euphoria Healthcare Pvt Ltd. | Center for Drug Evaluation and Research | Finished Pharmaceuticals / Unapproved New Drug / Misbranded |
| Sept. 6 | Crispy Delight Corp. | Division of Human and Animal Food Operations East I | CGMP / Food / Prepared, Packed or Held Under Insanitary Conditions / Adulterated |
| Sept. 6 | Sugarcreek Livestock Auction Inc. | Division of Human and Animal Food Operations East V (HAFE5) | CGMP / Medicated Feeds / Adulterated |
