Merz Pharma Gmbh & Co. KGaA
FDA inspection history in Reinheim, 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 Reinheim, Germany.
Cited most
Across all Merz Pharma Gmbh & Co. KGaA observations on file
- 21 CFR 820.90Nonconforming product2
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.30Design controls1
- 21 CFR 820.75Process validation1
The complete Merz Pharma Gmbh & Co. KGaA file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Reinheim, Germany
One Form 483 · 2022 · 5 observations
Latest: Form 483, Jun 10, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-06-10 | 483 Form 483 | Reinheim, Germany | 5 | $99 |
Investigators on these documents
FEI number 3006999111 · most recent document Jun 10, 2022
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 Jun 10, 2022.
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 Jun 10, 2022, for the site in Reinheim, 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 820.90 (Nonconforming product), 2 times; 21 CFR 820.100 (Corrective and preventive action), 1 time; 21 CFR 820.30 (Design controls), 1 time.