Overview
- 11 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-12.
At a glance
Inspections
11
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Jun 2024 – 12 Jun 2024 | Biologics | Clean | |
| 20 Jul 2021 – 21 Jul 2021 | Biologics | Clean | |
| 16 Sep 2019 – 26 Sep 2019 | Biologics | 483 | View 483 → |
| 19 Jun 2017 – 23 Jun 2017 | Biologics | Clean | |
| 16 Mar 2015 – 31 Mar 2015 | Biologics | Clean | |
| 11 Aug 2014 – 15 Aug 2014 | Human Drugs | 483 | On file |
| 25 Feb 2014 – 6 Mar 2014 | Biologics | Clean | |
| 7 Aug 2013 – 13 Aug 2013 | Biologics | Clean | |
| 4 Aug 2011 | Not recorded | Clean | |
| 19 Nov 2009 | Not recorded | Clean | |
| 8 Sep 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Sherry M Nisson4 insp.
Anthony N Onianwa2 insp.
Alan R Condon1 insp.
Alice C Silva1 insp.
Tamara M Kays1 insp.
Kent A Conforti1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.85(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Brigham And Women's Hospital's 2 Form 483s
Source PDFs 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