483
Sanofi Vaccines US Inc.Sanofi Vaccines US Inc. – FDA 483
Record Details
An FDA inspection of Sanofi Pasteur, Inc. in Swiftwater, PA, a vaccine manufacturer, revealed two significant observations. The firm failed to follow procedures for YF-VAX production operations, specifically regarding conveyor speed adjustments during lyophilizer unloading. Additionally, the firm did not adequately document or evaluate cycle failures associated with a specific line, with no investigation initiated to assess trends or impact on process validation.
- Company
- Sanofi Vaccines US Inc.
- Product type
- biologics
View Company Profile
ID · ecac1e06-2dca-4ed9-bfc8-8d7c8ebd3481
Other documents for Sanofi Vaccines US Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.