Laboratorios L.O., Oftalmi, C.A. – FDA Warning Letter, Mar 2, 2010

This FDA Warning Letter, dated May 12, 2010, was issued to Laboratorios L.O., Oftalmi, C.A. following an inspection from February 22-26 and March 1-2, 2010. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Failure to prevent microbiological contamination (21 CFR § 211.113(b)):** Media fill studies showed contamination in four of six batches, with inadequate documentation and organism identification. Operators exhibited deficient aseptic techniques (e.g., direct contact with sterile bottles, improper movements). The environmental monitoring program was inadequate, lacking active and non-viable air sampling during filling, and having insufficient sampling frequency. 2. **Inadequate investigation of out-of-specification (OOS) results (21 CFR § 211.192):** The firm invalidated initial OOS results without scientific justification. 3. **Lack of defined areas to prevent contamination/mix-ups during aseptic processing (21 CFR § 211.42(c)):** There was an inadequate assessment of cross-contamination risks from manufacturing hazardous compounds (beta-lactam antibiotics, steroids) in shared areas with sterile ophthal