Txsyn Int. LLC – FDA Warning Letter, Nov 14, 2023

On October 25 – November 14, 2023, the FDA inspected Txsyn Int. LLC at 7232 Eckhert Rd., Ste 7234, San Antonio, TX. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering their products adulterated under section 402(g)(1) of the Act.

Key violations include: 1. **Failure to retain reserve samples for the required duration (21 CFR 111.465(b))**: The company retained samples for an insufficient period, and provided no supporting documentation for claimed corrections. 2. **Lack of established and followed written procedures for received products (21 CFR 111.153)**: No procedures were in place for products received for packaging/labeling, such as THINK BOTANICALS IMMUNITY MUSHROOM gummy. The "Inbound Policy" provided was inadequate. 3. **Absence of written procedures for packaging and labeling operations (21 CFR 111.403)**: The provided documents (e.g., "PACKAGING DESIGN CHECKLIST," "Pre-Operation Procedure," "SOP for GMP Clean Room") did not cover all required aspects, such as examination of packaging/labels against master manufacturing records or examination of repackaged samples.