Txsyn Int. LLC
FDA issued a warning letter to Txsyn Int. LLC (San Antonio, TX) following an October–November 2023 inspection of their dietary supplement repackaging and labeling facility. The agency identified five significant CGMP violations under 21 CFR Part 111, including failure to retain reserve samples for required periods, lack of written procedures for received products, packaging/labeling operations, and returned dietary supplements, as well as releasing product for distribution without quality control approval. No marketing claims were flagged; the violations are entirely operational/manufacturing in nature, and FDA warned that failure to correct may result in seizure or injunction.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction.
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