Sanofi
Form 483 issued July 25, 2022 · Framingham, Massachusetts
- Observations
- 2
- Pages
- 2
- FEI number
- 1220423
In short: On July 25, 2022, FDA issued a Form 483 with 2 observations to Sanofi in Framingham, Massachusetts (FEI 1220423). Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×) · 211.58 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to exercise sufficient controls over computerized systems and failure to have adequate controls to…
- 02
Failure to properly maintain buildings and facilities used in the manufacture…
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. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was Sanofi inspected by FDA?
This Form 483 is dated July 25, 2022.
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.