Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-10-17.
At a glance
Inspections
7
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Oct 2023 – 17 Oct 2023 | Biologics | 483 | View 483 → |
| 5 Dec 2022 – 9 Dec 2022 | Biologics | 483 | On file |
| 22 Aug 2022 – 26 Aug 2022 | Human Drugs | 483 | On file |
| 15 Aug 2022 – 19 Aug 2022 | Human Drugs | 483 | View 483 → |
| 30 Apr 2018 – 4 May 2018 | Human Drugs | 483 | On file |
| 30 Nov 2015 – 10 Dec 2015 | Human Drugs | 483 | View 483 → |
| 13 Apr 2015 – 16 Apr 2015 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Oct 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Gene D Arcy, Latorie S Jones
17 Oct 2023
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Gene D Arcy, Latorie S Jones
17 Oct 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Gene D Arcy, Latorie S Jones
17 Oct 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Gene D Arcy, Latorie S Jones
17 Oct 2023
21 CFR 211.198(a)
Procedures to be written and followed
Cited by Gene D Arcy, Latorie S Jones
Investigators
FDA investigators tied to this site in the record.
Veronica Fuentes2 insp.
Song Y Lavalais2 insp.
Seneca D Toms2 insp.
Gene D Arcy1 insp.
Latorie S Jones1 insp.
Prajakta A Varadkar1 insp.
Gregory A Price1 insp.
Daniel Lagasse1 insp.
Alifiya H Ghadiali1 insp.
Wendy G Tan1 insp.
Esther C Broner1 insp.
Ephrem T Hunde1 insp.
Viviana Matta1 insp.
Adam R Cooke1 insp.
Sonya M Edmonds1 insp.
Christopher S Keating1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Biogen U.S. Corporation's 6 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