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

Source: https://www.keypedia.com/records/483/lilly-france-sas/041c69f4-4312-492a-881f-670b2cd26c17

> FDA 483 for Lilly France S.A.S. on September 29, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lilly France S.A.S.
- Inspection Date: 2022-09-29
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

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Company: https://www.keypedia.com/companies/lilly-france-sas/27fa7368-5fb0-48b1-b161-5729c7bfa061

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd