Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-22.
At a glance
Inspections
7
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Jun 2026 – 22 Jun 2026 | Human Drugs | 483 | View 483 → |
| 15 Mar 2023 – 11 Apr 2023 | Human Drugs | Clean | |
| 5 Aug 2021 – 16 Sep 2021 | Human Drugs | WL | View 483 → |
| 30 Jul 2019 – 22 Aug 2019 | Human Drugs | 483 | View 483 → |
| 30 Jul 2019 – 7 Aug 2019 | Human Drugs | Clean | |
| 7 Dec 2015 – 10 Dec 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Aug 2014 – 15 Aug 2014 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Jun 2026
21 CFR 212.30(a)
Orderly handling, prevention of mix-ups, prevention of contamination
Cited by Sean R Marcsisin, Ifechimere I Okafor
16 Sep 2021
21 CFR 212.20(d)
Determination need for investigation
Cited by Robert J Martin, Erik W Koester
16 Sep 2021
21 CFR 212.20(e)
Written QA procedures established, followed
Cited by Robert J Martin, Erik W Koester
16 Sep 2021
21 CFR 212.30(a)
Orderly handling, prevention of mix-ups, prevention of contamination
Cited by Robert J Martin, Erik W Koester
Investigators
FDA investigators tied to this site in the record.
Robert J Martin4 insp.
Sean R Marcsisin1 insp.
Ifechimere I Okafor1 insp.
Erik W Koester1 insp.
Stephen C Smith1 insp.
Tamara M Kays1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.30(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 212.20(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.20(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.18(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.30(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.30(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Brigham and Women's Hospital, Inc., The's 5 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