Sanofi S.p.A
Form 483 issued May 22, 2023 · Anagni, Italy
- Inspection
- May 12 – May 22, 2023
- Investigator
- Richard Ledwidge
- Observations
- 2
- Pages
- 2
- FEI number
- 3002807108
In short: On May 22, 2023, FDA issued a Form 483 with 2 observations to Sanofi S.p.A in Anagni, FR (FEI 3002807108) after an inspection that ran May 12 – May 22, 2023. The investigator was Richard Ledwidge. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Richard Ledwidge
18 documents · 2015–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.113
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 production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Sanofi S.p.A?
Richard Ledwidge is named on this Form 483, for the inspection of May 12 – May 22, 2023. Each investigator has a profile showing what they cite most.
When was Sanofi S.p.A inspected by FDA?
The inspection ran May 12 – May 22, 2023, and the Form 483 is dated May 22, 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.