Rommelag CDMO GmbH
FDA inspection history in Sulzbach-Laufen, Germany, 2020
- 1
- Form 483
Every document, by year
- Form 483
2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Sulzbach-Laufen, Germany.
Cited most
Across all Rommelag CDMO observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.166Stability testing1
- 21 CFR 211.192Production record review1
- 21 CFR 211.25Personnel qualifications1
- 21 CFR 314.81Other postmarketing reports1
The complete Rommelag CDMO file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Sulzbach-Laufen, Germany
One Form 483 · 2020 · 5 observations
Latest: Form 483, Feb 18, 2020 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-02-18 | 483 Form 483 | Sulzbach-Laufen, Germany | 5 | $99 |
Investigators on these documents
FEI number 3002808845 · most recent document Feb 18, 2020
About Rommelag CDMO GmbH
How many FDA Form 483s has Rommelag CDMO GmbH received?
FDA Intel has 1 Form 483 on file for Rommelag CDMO GmbH; the most recent is dated Feb 18, 2020.
When was Rommelag CDMO GmbH last inspected by FDA?
The most recent FDA inspection document on file for Rommelag CDMO GmbH is a Form 483 dated Feb 18, 2020, for the site in Sulzbach-Laufen, Germany.
What did FDA cite at Rommelag CDMO GmbH?
The regulations cited most in the observations on file for Rommelag CDMO GmbH are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.166 (Stability testing), 1 time; 21 CFR 211.192 (Production record review), 1 time.