Laboratorio Pharma International SRL – FDA Warning Letter, Sep 21, 2021

The FDA issued a Warning Letter to Laboratorio Pharma International S. de R.L. (FEI 3012015184) in Honduras, registered as an OTC drug manufacturer, following a review of records requested under section 704(a)(4) of the FD&C Act. The letter, dated September 15, 2021, identifies significant CGMP violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Laboratory Controls (21 CFR 211.160(b)):** Failure to establish appropriate specifications for active ingredients (lidocaine hydrochloride and menthol) in GELAZUL Topical Analgesic and lack of testing for incoming menthol components. 2. **Insufficient Stability Testing Program (21 CFR 211.166(a)):** Lack of an adequate program to support the 3-year expiry of GELAZUL and hand sanitizer products, including quantitative assay determinations. 3. **Failure to Test Components (21 CFR 211.84(d)(2)):** Inadequate testing for impurities and identity of incoming components, specifically ethyl alcohol for Pharmaint Gel Hand Sanitizer.

Additionally, GELAZUL Topical Analgesic is cited as an unapproved new drug (21 U.S