Merz Pharma GmbH & Co KGaA
FDA inspection history in Dessau-Rosslau, Germany, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Dessau-Rosslau, Germany.
Cited most
Across all Merz Pharma GmbH & Co KGaA observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 600.14Reporting of biological product deviations by licensed manufacturers1
The complete Merz Pharma GmbH & Co KGaA file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Dessau-Rosslau, Germany
One Form 483 · 2019 · 4 observations
Latest: Form 483, Nov 22, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-11-22 | 483 Form 483 | Dessau-Rosslau, Germany | 4 | $99 |
Investigators on these documents
FEI number 3006896175 · most recent document Nov 22, 2019
About Merz Pharma GmbH & Co KGaA
How many FDA Form 483s has Merz Pharma GmbH & Co KGaA received?
FDA Intel has 1 Form 483 on file for Merz Pharma GmbH & Co KGaA; the most recent is dated Nov 22, 2019.
When was Merz Pharma GmbH & Co KGaA last inspected by FDA?
The most recent FDA inspection document on file for Merz Pharma GmbH & Co KGaA is a Form 483 dated Nov 22, 2019, for the site in Dessau-Rosslau, Germany.
What did FDA cite at Merz Pharma GmbH & Co KGaA?
The regulations cited most in the observations on file for Merz Pharma GmbH & Co KGaA are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time.