# FDA WARNING_LETTER - Sanofi Pasteur - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/sanofi-pasteur/83df4bd6-3bef-4f07-88ad-284d3832d2d7

> FDA WARNING_LETTER for Sanofi Pasteur on Unknown Date. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sanofi Pasteur
- Product Type: Biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: 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

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Company: https://www.keypedia.com/companies/sanofi-pasteur/851434de-295b-430d-b638-f2e9f50b0531

Office: https://www.keypedia.com/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d