TCT Nutraceuticals SDN. BHD – FDA Warning Letter, Jun 11, 2024

The FDA issued a Warning Letter to TCT Nutraceuticals SDN. BHD. on June 5, 2024, following a review of records submitted in response to a Section 704(a)(4) request. The facility, registered as an OTC drug product manufacturer, was found to have significant Current Good Manufacturing Practice (CGMP) violations, rendering its drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to verify component identity (21 CFR 211.84(d)(1)):** The firm did not adequately test incoming components, including isopropyl alcohol for methanol, used in its Antibacterial Hand Sanitizer Gel. 2. **Inadequate finished drug product testing (21 CFR 211.165(a)):** The firm failed to conduct appropriate laboratory determinations for final specifications, including identity and strength of active ingredients, and did not provide test methods or method validation. 3. **Lack of an adequate stability testing program (21 CFR 211.166(a)):** The firm lacked sufficient data to support the chemical and microbiological stability of its drug products throughout their labeled expiry, with provided stability results limited to basic physical attributes.

The FDA noted the firm's quality systems are inadequate and recommended engaging a qualified CGMP consultant to perform a comprehensive six-system