Sanofi Vaccines US Inc. – FDA 483, Apr 28, 2006

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