Sisley Industrie
Form 483 issued April 19, 2024 · Villebarou, France
- Inspection
- Apr 15 – Apr 19, 2024
- Investigator
- Gretchen L. Trendel
- Observations
- 2
- Pages
- 3
- FEI number
- 3010164501
In short: On April 19, 2024, FDA issued a Form 483 with 2 observations to Sisley Industrie in Villebarou, CENTRE VAL DE LOIRE (FEI 3010164501) after an inspection that ran Apr 15 – Apr 19, 2024. The investigator was Gretchen L. Trendel. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 1 system, led by laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 02
The responsibilities and procedures applicable to the quality unit are not in…
This inspection in context
Gretchen L. Trendel
6 documents · 2021–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kansas.
The firmSisley Industrie history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sisley Industrie?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Sisley Industrie?
Gretchen L. Trendel is named on this Form 483, for the inspection of Apr 15 – Apr 19, 2024. Each investigator has a profile showing what they cite most.
When was Sisley Industrie inspected by FDA?
The inspection ran Apr 15 – Apr 19, 2024, and the Form 483 is dated April 19, 2024.
How do I get the full Form 483 for Sisley Industrie?
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.