Biogen International GmbH
FDA inspection history in Luterbach, Switzerland, 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 Luterbach, Switzerland.
Cited most
Across all Biogen International observations on file
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Biogen International file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Luterbach, Switzerland
One Form 483 · 2022 · 4 observations
Latest: Form 483, Mar 29, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-03-29 | 483 Form 483 | Luterbach, Switzerland | 4 | $99 |
Investigators on these documents
FEI number 3017081436 · most recent document Mar 29, 2022
About Biogen International GmbH
How many FDA Form 483s has Biogen International GmbH received?
FDA Intel has 1 Form 483 on file for Biogen International GmbH; the most recent is dated Mar 29, 2022.
When was Biogen International GmbH last inspected by FDA?
The most recent FDA inspection document on file for Biogen International GmbH is a Form 483 dated Mar 29, 2022, for the site in Luterbach, Switzerland.
What did FDA cite at Biogen International GmbH?
The regulations cited most in the observations on file for Biogen International GmbH are 21 CFR 211.111 (Time limitations on production), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.194 (Laboratory records), 1 time.