Merck Biodevelopment
FDA inspection history in Martillac, France, 2022
- 2
- Form 483s
Every document, by year
- Form 483
2022: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2022Two Form 483s, at Martillac, France.
- 2022The longest 483 on file: 10 observations over 7 pages at Martillac, France.
Cited most
Across all Merck Biodevelopment observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.160General requirements2
- 21 CFR 211.182Equipment cleaning and use log1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Merck Biodevelopment file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Martillac, France
Two Form 483s · 2022 · 13 observations
Latest: Form 483, Oct 14, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-10-14 | 483 Form 483 | Martillac, France | 10 | $99 |
| 2022-05-24 | 483 Form 483 | Martillac, France | 3 | $99 |
Investigators on these documents
Chen Sun (1)Jeanne Fringer (1)Matthew B. Casale (1)Richard Ledwidge (1)Rong Wang (1)
FEI number 3009563840 · most recent document Oct 14, 2022
About Merck Biodevelopment
How many FDA Form 483s has Merck Biodevelopment received?
FDA Intel has 2 Form 483s on file for Merck Biodevelopment; the most recent is dated Oct 14, 2022.
When was Merck Biodevelopment last inspected by FDA?
The most recent FDA inspection document on file for Merck Biodevelopment is a Form 483 dated Oct 14, 2022, for the site in Martillac, France.
What did FDA cite at Merck Biodevelopment?
The regulations cited most in the observations on file for Merck Biodevelopment are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.160 (General requirements), 2 times.