FDA Issued A Form FDA 483 To Sanofi Pasteur's PA Vaccine Plant

The Food and Drug Administration (FDA) conducted an inspection of Sanofi Pasteur, Inc. (Sanofi), Discovery Drive, Swiftwater, Pennsylvania, between April 18 and April 28, 2006. During the inspection, FDA investigators documented significant deviations from current good manufacturing practices (CGMP) in the manufacture of licensed biological products and Fluzone® monovalent concentrate batches. These deviations from CGMP include the applicable requirements of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 351(a) of the Public Health Service Act (PHS Act), and Title 21, Code of Federal Regulations, (21 CFR) Parts 210, 211, and 600-680.

At the close of the inspection, FDA issued a Form FDA 483, Inspectional Observations, that described a number of significant objectionable conditions relating to your facility's compliance with CGMP.

SOURCE: FDA