CIS Bio International
FDA inspection history in Gif sur Yvette, France, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Gif sur Yvette, France.
Cited most
Across all CIS Bio International observations on file
- 21 CFR 211.165(e)Testing and release for distribution2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.180(e)(1)General requirements1
- 21 CFR 211.192Production record review1
The complete CIS Bio International file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Gif sur Yvette, France
One Form 483 · 2022 · 8 observations
Latest: Form 483, Dec 16, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-16 | 483 Form 483 | Gif sur Yvette, France | 8 | $99 |
Investigators on these documents
FEI number 1000268008 · most recent document Dec 16, 2022
About CIS Bio International
How many FDA Form 483s has CIS Bio International received?
FDA Intel has 1 Form 483 on file for CIS Bio International; the most recent is dated Dec 16, 2022.
When was CIS Bio International last inspected by FDA?
The most recent FDA inspection document on file for CIS Bio International is a Form 483 dated Dec 16, 2022, for the site in Gif sur Yvette, France.
What did FDA cite at CIS Bio International?
The regulations cited most in the observations on file for CIS Bio International are 21 CFR 211.165(e) (Testing and release for distribution), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time.