Gemini PharmChem Mannheim GmbH
FDA inspection history in Mannheim, Germany, 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 Mannheim, Germany.
Cited most
Across all Gemini PharmChem Mannheim observations on file
- 21 CFR 211.192Production record review1
- 21 CFR 211.80General requirements1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Gemini PharmChem Mannheim file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Mannheim, Germany
One Form 483 · 2022 · 3 observations
Latest: Form 483, Jan 21, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-01-21 | 483 Form 483 | Mannheim, Germany | 3 | $99 |
FEI number 3014000756 · most recent document Jan 21, 2022
About Gemini PharmChem Mannheim GmbH
How many FDA Form 483s has Gemini PharmChem Mannheim GmbH received?
FDA Intel has 1 Form 483 on file for Gemini PharmChem Mannheim GmbH; the most recent is dated Jan 21, 2022.
When was Gemini PharmChem Mannheim GmbH last inspected by FDA?
The most recent FDA inspection document on file for Gemini PharmChem Mannheim GmbH is a Form 483 dated Jan 21, 2022, for the site in Mannheim, Germany.
What did FDA cite at Gemini PharmChem Mannheim GmbH?
The regulations cited most in the observations on file for Gemini PharmChem Mannheim GmbH are 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.80 (General requirements), 1 time; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 1 time.