Eli Lilly Italia SPA
Form 483 issued February 10, 2023 · Sesto Fiorentino, Italy
- Inspection
- Feb 2 – Feb 10, 2023
- Observations
- 2
- Pages
- 2
- FEI number
- 3002806895
In short: On February 10, 2023, FDA issued a Form 483 with 2 observations to Eli Lilly Italia SPA in Sesto Fiorentino, FI (FEI 3002806895) after an inspection that ran Feb 2 – Feb 10, 2023. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.63 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture of drug product is not of optimum design to facilitate operations…
- 02
Your firm failed to establish or follow written procedures for production and process controls designed to…
This inspection in context
Questions about this 483
What did FDA find at Eli Lilly Italia SPA?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
When was Eli Lilly Italia SPA inspected by FDA?
The inspection ran Feb 2 – Feb 10, 2023, and the Form 483 is dated February 10, 2023.
How do I get the full Form 483 for Eli Lilly Italia SPA?
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.