Sanofi Winthrop Industrie – FDA Warning Letter

The FDA issued a Warning Letter to Sanofi Pasteur S.A. and Sanofi Pasteur Limited following inspections in March-April 2012, citing significant deviations from CGMP requirements for licensed biological drug products and intermediates.

At Sanofi Pasteur Limited (Toronto), violations included: * **Sterility Assurance:** Failure to validate BCG Sterility Test Method (21 CFR 211.165(e)), with revalidation failing acceptance criteria and 58 documented mold non-conformances in aseptic areas since August 2010. Manufacturing of TheraCys® (BCG-IT) was temporarily suspended. * **Environmental Monitoring:** Inadequate environmental monitoring system (21 CFR 211.42(c)(10)(iv)), with insufficient air monitoring frequency and lack of goggle monitoring. * **Cleaning/Disinfection:** Inadequate cleaning and disinfection of aseptic areas (21 CFR 211.42(c)(10)(v)), with disinfectant efficacy studies not evaluating all surfaces and infrequent sporicidal disinfection. * **Aseptic Processing:** Failure to follow written procedures for preventing microbiological contamination and validate aseptic processes (21 CFR 211.113(b)), including operator aseptic technique deviations and lack of SOPs for certain BCG aseptic operations. * **Stability Testing:** Failure to establish a written stability testing program (21 CFR