Merck Serono SPA
FDA inspection history in Bari, Italy, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Bari, Italy.
Cited most
Across all Merck Serono SPA observations on file
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.56Sanitation1
- 21 CFR 211.63Equipment design, size, and location1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Merck Serono SPA file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Bari, Italy
One Form 483 · 2023 · 5 observations
Latest: Form 483, May 10, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-05-10 | 483 Form 483 | Bari, Italy | 5 | $99 |
Investigators on these documents
FEI number 3003581732 · most recent document May 10, 2023
About Merck Serono SPA
How many FDA Form 483s has Merck Serono SPA received?
FDA Intel has 1 Form 483 on file for Merck Serono SPA; the most recent is dated May 10, 2023.
When was Merck Serono SPA last inspected by FDA?
The most recent FDA inspection document on file for Merck Serono SPA is a Form 483 dated May 10, 2023, for the site in Bari, Italy.
What did FDA cite at Merck Serono SPA?
The regulations cited most in the observations on file for Merck Serono SPA are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.56 (Sanitation), 1 time.