FDA WARNING_LETTER - Mylan Laboratories Limited - February 13, 2015

The FDA issued a Warning Letter to Mylan Laboratories Limited on August 6, 2015, following inspections of three pharmaceutical manufacturing facilities in Bangalore, India: Mylan Laboratories Limited OTL (Feb 2015), Agila Specialties Private Ltd., Specialty Formulation Facility (SFF) (Sep-Oct 2014), and Agila Specialties Private Ltd., Sterile Product Division (SPD) (Aug 2014).

Significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211) were identified at all three sites, rendering their drug products adulterated. The FDA found Mylan's responses to be insufficient.

Key violations at Mylan Laboratories Limited OTL included: - Failure to prevent microbiological contamination in sterile drug products (21 CFR 211.113(b)): Use of non-integral gloves with tears/pinholes, inadequate environmental monitoring (repeated out-of-action-level results, lack of trend analysis), deficient personnel monitoring (operators not sanitizing hands, sanitizing before EM checks), and non-integral aseptic garments. - Inadequate laboratory controls (21 CFR 211.160(b)): Failure to follow water sampling SOPs (samples not collected but reported), and unreliable environmental monitoring data due to desiccated media plates. - Inadequate environmental monitoring system (21 CFR 211