Sanofi
Form 483 issued July 9, 2024 · Framingham, Massachusetts
- Inspection
- Jan 9 – Jul 9, 2024
- Observations
- 6
- Pages
- 8
- FEI number
- 1220423
In short: On July 9, 2024, FDA issued a Form 483 with 6 observations to Sanofi in Framingham, Massachusetts (FEI 1220423) after an inspection that ran Jan 9 – Jul 9, 2024. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Quality system and production account for 4 of 6 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to adequately investigate significant deviations regarding…
- 02
Failure to demonstrate that your manufacturing process can reproducibly manufacture drug substance meeting…
- 03
Failure to have equipment of the appropriate design for their intended use for the…
- 04
Failure of your quality unit to exercise its responsibility to ensure that bulk drug substance manufactured…
This inspection in context
Questions about this 483
What did FDA find at Sanofi?
FDA listed 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was Sanofi inspected by FDA?
The inspection ran Jan 9 – Jul 9, 2024, and the Form 483 is dated July 9, 2024.
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.