The U.S. Food and Drug Administration issued 18 warning letters in August 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 August
| Issue Date | Company
Name | Issuing Office | Subject |
| Aug. 26 | Agroson's LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP)/Adulterated |
| Aug. 15 | H & A Walters Fulfillment Center | Center for Food Safety and Applied Nutrition | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Aug. 15 | Dandong Shenghai Foodstuff Co. Ltd. | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Aug. 13 | Ningbo Pulisi Daily Chemical Products Co. Ltd | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Aug. 8 | Sunshine International Foods Inc. | Center for Food Safety and Applied Nutrition | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions |
| Aug. 8 | Lantech Pharmaceuticals Limited | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Aug. 8 | Hookah Imports Inc | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| Aug. 8 | Mighty Vapors, LLC, d/b/a Ovo Manufacturing & Distribution | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| Aug. 8 | Liquid Labs USA, LLC, d/b/a Likido Labs USA | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| Aug. 8 | V8P Juice International LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| Aug. 6 | Let's Talk Health, Inc. | Division of Human and Animal Food Operations West V | Unapproved New Drugs/Misbranded |
| Aug. 6 | Deva Holding AS - Cerkezkoy Subesi | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug. 6 | T&W LLC | Office of Human and Animal Food Division 5 West | Airline Catering Facility/Adulterated/Misbranded |
| Aug. 2 | NingBo Huize Commodity Co. Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Aug. 2 | Emcure Pharmaceuticals Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug. 2 | Min Jiang Food Store Inc., dba Koi Koi Trading | Office of Human and Animal Food Division 5 West | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Aug. 2 | TALON, an S & S Technology Company | Office of Medical Device and Radiological Health Operations, Division 3 | CGMP/QSR/Drug/Medical Devices/Adulterated |
| Aug. 1 | TG United Inc. | Office of Pharmaceutical Quality Operations, Division II | CGMP/Finished Pharmaceuticals/Adulterated |
