Thursday, September 19, 2019

Thursday, September 19, 2019

FDA issued 18 warning letters to companies in August


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.

---

FDA Warning Letters Issued in August

Issue DateCompany

Name

Issuing OfficeSubject
Aug. 26Agroson's LLCDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)/Adulterated
Aug. 15H & A Walters Fulfillment CenterCenter for Food Safety and Applied NutritionCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Aug. 15Dandong Shenghai Foodstuff Co. Ltd.Center for Food Safety and Applied NutritionSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Aug. 13Ningbo Pulisi Daily Chemical Products Co. LtdCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Aug. 8Sunshine International Foods Inc.Center for Food Safety and Applied NutritionCGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Aug. 8Lantech Pharmaceuticals LimitedCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Aug. 8Hookah Imports IncCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Aug. 8Mighty Vapors, LLC, d/b/a Ovo Manufacturing & DistributionCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Aug. 8Liquid Labs USA, LLC, d/b/a Likido Labs USACenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Aug. 8V8P Juice International LLCCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Aug. 6Let's Talk Health, Inc.Division of Human and Animal Food Operations West VUnapproved New Drugs/Misbranded
Aug. 6Deva Holding AS - Cerkezkoy SubesiCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated
Aug. 6T&W LLCOffice of Human and Animal Food Division 5 WestAirline Catering Facility/Adulterated/Misbranded
Aug. 2 NingBo Huize Commodity Co. Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Aug. 2Emcure Pharmaceuticals LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated
Aug. 2Min Jiang Food Store Inc., dba Koi Koi TradingOffice of Human and Animal Food Division 5 WestSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Aug. 2TALON, an S & S Technology CompanyOffice of Medical Device and Radiological Health Operations, Division 3CGMP/QSR/Drug/Medical Devices/Adulterated
Aug. 1TG United Inc.Office of Pharmaceutical Quality Operations, Division IICGMP/Finished Pharmaceuticals/Adulterated
Source: U.S. Food and Drug Administration

Organizations in this Story

U.S. Food and Drug Administration (FDA)

More News

FDA Reporter