# FDA 483 - Sanofi Pasteur Inc. - April 28, 2006

Source: https://www.keypedia.com/records/483/sanofi-pasteur-inc/bde995cd-46d2-484f-a76e-e96d0512702d

> FDA 483 for Sanofi Pasteur Inc. on April 28, 2006. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanofi Pasteur Inc.
- Inspection Date: 2006-04-28
- Office Name: Office of Regulatory Affairs
- Summary: This FDA Form 483 details numerous observations from an inspection on April 19, 2006, concerning the manufacturing of influenza concentrate and other vaccines.

**Facility and Operations:** The inspection covered operations in Building 37 (influenza manufacturing, including filtration in Room 113), Building 46 (autoclaves, aseptic sampling in Room 237, and filling lines 1 and 4), and general practices related to seed lot storage, stability programs, and quality assurance.

**Violations and Observations:**
*   **Aseptic Processing and Contamination Control:**
    *   Operators returned to Class B areas without re-gowning after cleaning Class C areas.
    *   A common hallway (Hallway 135) lacked adequate segregation, leading to cross-contamination risks between early production materials (egg candling) and sterile processing. Contaminating organisms in sterile-filtered influenza concentrate were primarily egg-related.
    *   Wet/dry vacuums used for cleaning classified areas lacked routine HEPA filter integrity testing and interior drum sanitization, posing bioburden risks.
    *   Cleaning of Grade A surfaces was inconsistent with SOPs; disinfectants were not wiped after dwell time, and qualification studies did not specify wiping.
    *   Vent filters on sterile bulk concentrate tanks and dispensing siphon units were not integrity tested.
    *   Aseptic sampling area (Room 23

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Company: https://www.keypedia.com/companies/sanofi-pasteur-inc/94f5ecde-ae72-47f6-b6b7-ca9126ef544f

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64