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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 Date | Company Name | Issuing Office | Subject |
| July 22 | Curaleaf Inc. | Center for Drug Evaluation and Research | Unapproved New Drugs/ Misbranded/ Cannabidiol (CBD) Products |
| July 17 | Nor-Scot Trading Limited | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/ Adulterated/ Misbranded |
| July 16 | Indoco Remedies Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/ Adulterated |
| July 16 | AB Seafood Trading Inc. | Division of Human and Animal Food Operations East I | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| July 15 | Port Clyde Fresh Catch Inc. | Division of Human and Animal Food Operations East I | Seafood HACCP/CGMP for Foods/ Adulterated/ Insanitary Conditions |
| July 12 | EFF Marketing LTD d/b/a Cigara | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/ Adulterated/ Misbranded |
| July 12 | Origin Vape | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/ Adulterated/ Misbranded |
| July 12 | Monkey Vapors | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/ Adulterated/ Misbranded |
| July 11 | American Sales Company Inc. | Center for Drug Evaluation and Research | Failure to Comply with Drug Listing Requirements |
| July 9 | Ceba-Tek Inc. | Office of Human and Animal Food Operations Division IV East | CGMP/ Dietary Supplement/ Adulterated/ Misbranded |
| July 2 | High Chemical Company, Division of National Generic Distributors | Division of Pharmaceutical Quality Operations I | CGMP/ Active Pharmaceutical Ingredient (API)/ Adulterated |
| July 1 | Stratus BioSystems LLC | Center for Biologics Evaluation and Research | Deviations/ CFR/ Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| July 1 | Strides Pharma Science Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated |
| July 1 | Virginia Center for Reproductive Medicine | Division of Biological Products Operations I | Deviations/ CFR/ Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
