SGS France Life Sciences
Form 483 issued August 29, 2025 · Saint Benoit, France
- Inspection
- Aug 25 – Aug 29, 2025
- Investigators
- Ruben C. Ayala· Xingfang Li
- Observations
- 4
- Pages
- 3
- FEI number
- 3005865090
In short: On August 29, 2025, FDA issued a Form 483 with 4 observations to SGS France Life Sciences in Saint Benoit, Cedex (FEI 3005865090) after an inspection that ran Aug 25 – Aug 29, 2025. The investigators were Ruben C. Ayala and Xingfang Li. The most-cited regulation is 21 CFR 320.29 (analytical methods for an in vivo bioavailability or bioequivalence study).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Not all tested analytical sequences were conveyed in method validation report # (b)(4) and bioanalytical report…
- 03
Not all method validation experiments were documented contemporaneously, and it was difficult to verify…
- 04
Not all established SOPs were followed during method…
This inspection in context
Ruben C. Ayala
1 document · 2025
Cites 320.29 (analytical methods for an in vivo bioavailability or bioequivalence study) more than any other section. Most of their documents are for sites in France.
The firmSGS France Life Sciences history
The site's inspection history, in date order.
Similar 483sOther sites cited under 320.29
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SGS France Life Sciences?
FDA listed 4 observations on this Form 483. The most-cited regulation is 21 CFR 320.29 (analytical methods for an in vivo bioavailability or bioequivalence study). The opening words of each observation are shown on this page.
Who inspected SGS France Life Sciences?
Ruben C. Ayala and Xingfang Li are named on this Form 483, for the inspection of Aug 25 – Aug 29, 2025. Each investigator has a profile showing what they cite most.
When was SGS France Life Sciences inspected by FDA?
The inspection ran Aug 25 – Aug 29, 2025, and the Form 483 is dated August 29, 2025.
How do I get the full Form 483 for SGS France Life Sciences?
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.