Overview
- 21 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-11-04.
At a glance
Inspections
21
Form 483s
10
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Nov 2022 – 4 Nov 2022 | Human Drugs | Clean | |
| 31 Aug 2022 – 2 Sep 2022 | Human Drugs | Clean | |
| 26 Oct 2020 – 10 Nov 2020 | Human Drugs | 483 | On file |
| 25 Aug 2020 – 1 Sep 2020 | Human Drugs | Clean | |
| 13 Feb 2018 | Biologics | Clean | |
| 27 Mar 2017 – 6 Apr 2017 | Human Drugs | 483 | View 483 → |
| 26 Jan 2016 – 9 Feb 2016 | Human Drugs | 483 | On file |
| 22 Jun 2015 – 26 Jun 2015 | Human Drugs | 483 | View 483 → |
| 24 Jun 2014 – 3 Jul 2014 | Human Drugs | 483 | View 483 → |
| 14 Oct 2013 – 18 Oct 2013 | Human Drugs | 483 | On file |
| 4 Mar 2013 – 15 Mar 2013 | Human Drugs | 483 | On file |
| 27 Jun 2012 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Apr 2017
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by John P Mistler, Erik W Koester, Richard A Abate
6 Apr 2017
21 CFR 314.80(c)(2)
Late submission of annual safety reports
Cited by John P Mistler, Erik W Koester, Richard A Abate
3 Jul 2014
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by Justine M Corson, Jonathan G Matrisciano
Investigators
FDA investigators tied to this site in the record.
Matthew C Watson2 insp.
Megan A Haggerty2 insp.
Shirley S Wen1 insp.
Byungja E Marciante1 insp.
Justin A Boyd1 insp.
Mihaly S Ligmond1 insp.
Li Yun Huang1 insp.
Ze Peng1 insp.
John P Mistler1 insp.
Erik W Koester1 insp.
Richard A Abate1 insp.
Simone E Pitts1 insp.
Robert C Horan1 insp.
Justine M Corson1 insp.
Jonathan G Matrisciano1 insp.
Bo Chi1 insp.
Paul L Bellamy1 insp.
Darin S Wiegers1 insp.
Debra M Emerson1 insp.
Thomas J Arista1 insp.
Stacey S Degarmo1 insp.
Rory Geyer1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Biogen Inc.'s 10 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat