FDA 483 - Lilly France S.A.S. - September 29, 2022

This FDA Form 483 report details significant deficiencies at Lilly France SAS in Fegersheim, France, a drug product manufacturer. Observations primarily concern inadequate written procedures, ineffective contamination prevention, deviations from validated parameters, and poor facility maintenance. These issues indicate a moderate level of severity regarding GMP compliance for sterile drug product manufacturing.