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483
•Lilly France S.A.S.•September 29, 2022

Lilly France S.A.S. – FDA 483, Sep 29, 2022

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)
View Company Profile

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

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