Biogen Idec Inc.
FDA inspection history across 2 sites, 2013 to 2021
- 4
- Form 483s
Every document, by year
- Form 483
2013: one Form 483; 2017: one Form 483; 2019: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One Form 483, at RTP, North Carolina.
- 2017–21Three Form 483s, at Morrisville, North Carolina.
- 2021The longest 483 on file: 6 observations over 5 pages at Morrisville, North Carolina.
Cited most
Across all Biogen Idec observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.194Laboratory records4
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.165Testing and release for distribution1
The complete Biogen Idec file.
All 4 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
Three Form 483s · 2017 to 2021 · 17 observations
Latest: Form 483, Jun 16, 2021 →RTP, North Carolina
One Form 483 · 2013 · 2 observations
Latest: Form 483, Aug 2, 2013 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-06-16 | 483 Form 483 | Morrisville, North Carolina | 6 | $99 |
| 2019-02-15 | 483 Form 483 | Morrisville, North Carolina | 5 | $99 |
| 2017-03-23 | 483 Form 483 | Morrisville, North Carolina | 6 | $99 |
| 2013-08-02 | 483 Form 483 | RTP, North Carolina | 2 | $99 |
Investigators on these documents
Burnell M. Henry (1)Cynthia Jim (1)Jose A. Cruz-Gonzalez (1)Seneca Toms (1)Susan M. Jackson (1)Wayne Seifert (1)Zhao Wang (1)
FEI number 3000719749 · most recent document Jun 16, 2021
About Biogen Idec Inc.
How many FDA Form 483s has Biogen Idec Inc. received?
FDA Intel has 4 Form 483s on file for Biogen Idec Inc.; the most recent is dated Jun 16, 2021.
When was Biogen Idec Inc. last inspected by FDA?
The most recent FDA inspection document on file for Biogen Idec Inc. is a Form 483 dated Jun 16, 2021, for the site in Morrisville, North Carolina.
What did FDA cite at Biogen Idec Inc.?
The regulations cited most in the observations on file for Biogen Idec Inc. are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.194 (Laboratory records), 4 times; 21 CFR 211.100 (Written procedures; deviations), 2 times.