Lilly France
Form 483 issued September 29, 2022 · Fegersheim, France
- Inspection
- Sep 21 – Sep 29, 2022
- Observations
- 6
- Pages
- 3
- FEI number
- 3002807475
In short: On September 29, 2022, FDA issued a Form 483 with 6 observations to Lilly France in Fegersheim, France (FEI 3002807475) after an inspection that ran Sep 21 – Sep 29, 2022. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 4 of 6 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established that describe the endotoxin tests to be conducted on appropriate samples…
- 02
There is a lack of assurance that your procedures used for product-contact equipment used to manufacture…
- 03
Written production and process control procedures are not in accordance…
- 04
Procedures designed to prevent microbiological contamination of drug product purporting to…
This inspection in context
Questions about this 483
What did FDA find at Lilly France?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Lilly France inspected by FDA?
The inspection ran Sep 21 – Sep 29, 2022, and the Form 483 is dated September 29, 2022.
How do I get the full Form 483 for Lilly France?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.