Biogen U.S. Corporation
FDA inspection history in Morrisville, North Carolina, 2022 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23Two Form 483s, at Morrisville, North Carolina.
- 2023The longest 483 on file: 5 observations over 10 pages at Morrisville, North Carolina.
Cited most
Across all Biogen U.S. observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.198(a)Complaint files1
The complete Biogen U.S. 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
Morrisville, North Carolina
Two Form 483s · 2022 to 2023 · 6 observations
Latest: Form 483, Oct 17, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-17 | 483 Form 483 | Morrisville, North Carolina | 5 | $99 |
| 2022-08-26 | 483 Form 483 | Morrisville, North Carolina | 1 | $99 |
Investigators on these documents
Gene D. Arcy (1)Latorie S. Jones (1)Song Y. Lavalais (1)Veronica Fuentes (1)
FEI number 3010164829 · most recent document Oct 17, 2023
About Biogen U.S. Corporation
How many FDA Form 483s has Biogen U.S. Corporation received?
FDA Intel has 2 Form 483s on file for Biogen U.S. Corporation; the most recent is dated Oct 17, 2023.
When was Biogen U.S. Corporation last inspected by FDA?
The most recent FDA inspection document on file for Biogen U.S. Corporation is a Form 483 dated Oct 17, 2023, for the site in Morrisville, North Carolina.
What did FDA cite at Biogen U.S. Corporation?
The regulations cited most in the observations on file for Biogen U.S. Corporation are 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.160(b) (General requirements), 1 time.