Sanofi S.p.A
Form 483 issued February 2, 2023 · Anagni, Italy
- Inspection
- Jan 30 – Feb 2, 2023
- Investigator
- Joshua J. Silvestri
- Observations
- 2
- Pages
- 5
- FEI number
- 3002807108
In short: On February 2, 2023, FDA issued a Form 483 with 2 observations to Sanofi S.p.A in Anagni, Frosinone (FEI 3002807108) after an inspection that ran Jan 30 – Feb 2, 2023. The investigator was Joshua J. Silvestri. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.100 (1×) · 820.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Joshua J. Silvestri
8 documents · 2019–2025
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Georgia.
The firmSanofi S.p.A history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sanofi S.p.A?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Sanofi S.p.A?
Joshua J. Silvestri is named on this Form 483, for the inspection of Jan 30 – Feb 2, 2023. Each investigator has a profile showing what they cite most.
When was Sanofi S.p.A inspected by FDA?
The inspection ran Jan 30 – Feb 2, 2023, and the Form 483 is dated February 2, 2023.
How do I get the full Form 483 for Sanofi S.p.A?
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.