Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistTxsyn Int. LLC, a dietary supplement manufacturer in San Antonio, Texas, was found to have produced adulterated products due to significant Current Good Manufacturing Practice (CGMP) violations during an FDA inspection conducted October–November 2023. The company failed to retain reserve samples for the required time period—specifically retaining them for less than the mandated one year past shelf-life expiration date or two years from distribution, as required under 21 CFR 111.465(b). These violations rendered the dietary supplements adulterated under the Federal Food, Drug, and Cosmetic Act, and the company's written responses to the inspection findings (submitted December 2023–January 2024) were found inadequate to address the deficiencies.