FDA WARNING_LETTER - Xtreme Tools International, Inc. - January 31, 2025

On June 25, 2025, the FDA issued a Warning Letter to Xtreme Tools International, Inc. following an inspection from January 27-31, 2025, at their Opa Locka, FL facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

The FDA found Xtreme Tools International, Inc.'s February 20, 2025, response to the Form FDA 483 inadequate due to insufficient supportive documentation and evidence of corrective actions.

Key violations include: 1. **Inadequate Component Testing (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm failed to verify the identity of each component, including salicylic acid API, and did not validate supplier test analyses. Specifically, they did not adequately test glycerin and propylene glycol for diethylene glycol (DEG) and ethylene glycol (EG) contamination, which are high-risk impurities. Water used in manufacturing was also not demonstrated to meet USP monograph requirements. 2. **Insufficient Finished Product Release Testing (21 CFR 211.165(a) and 211.165(b)):** The firm failed to conduct appropriate