Rommelag CDMO Switzerland AG
FDA inspection history in Zell, Switzerland, 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 Zell, Switzerland.
Cited most
Across all Rommelag CDMO Switzerland AG observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Rommelag CDMO Switzerland AG file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Zell, Switzerland
One Form 483 · 2022 · 3 observations
Latest: Form 483, Feb 11, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-02-11 | 483 Form 483 | Zell, Switzerland | 3 | $99 |
FEI number 3004079469 · most recent document Feb 11, 2022
About Rommelag CDMO Switzerland AG
How many FDA Form 483s has Rommelag CDMO Switzerland AG received?
FDA Intel has 1 Form 483 on file for Rommelag CDMO Switzerland AG; the most recent is dated Feb 11, 2022.
When was Rommelag CDMO Switzerland AG last inspected by FDA?
The most recent FDA inspection document on file for Rommelag CDMO Switzerland AG is a Form 483 dated Feb 11, 2022, for the site in Zell, Switzerland.
What did FDA cite at Rommelag CDMO Switzerland AG?
The regulations cited most in the observations on file for Rommelag CDMO Switzerland AG are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.