Sanofi
Form 483 issued September 4, 2020 · Framingham, Massachusetts
- Inspection
- Sep 4, 2020
- Observations
- 2
- Pages
- 2
- FEI number
- 1220423
In short: On September 4, 2020, FDA issued a Form 483 with 2 observations to Sanofi in Framingham, Massachusetts (FEI 1220423) after an inspection that ran Sep 4, 2020. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Facilities and equipment supporting manufacture…
- 02
Equipment used within the QC Microbiology Laboratory has not been adequately certified and review of logbooks…
This inspection in context
Questions about this 483
What did FDA find at Sanofi?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Sanofi inspected by FDA?
The inspection ran Sep 4, 2020, and the Form 483 is dated September 4, 2020.
How do I get the full Form 483 for Sanofi?
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.