Lilly France S.A.S.September 29, 2022

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

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Record Details

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.

Company: Lilly France S.A.S.
Inspection Date: September 29, 2022
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Marcellinus D. Dordunoo (Investigator)
Wendy Guat Hoon Tan (investigator)

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ID · 041c69f4-4312-492a-881f-670b2cd26c17