Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-11-20.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Nov 2024 – 20 Nov 2024 | Biologics | Clean | |
| 6 Jul 2022 – 8 Jul 2022 | Biologics | Clean | |
| 18 Jan 2019 – 23 Jan 2019 | Biologics | Clean | |
| 20 Jun 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Jun 2011
21 CFR 1271.200(b)
Procedures inadequate
Cited by Leena Thomas, Susan T Hadman, Haydee B Romero
20 Jun 2011
21 CFR 1271.210(a)
Use prior to verification
Cited by Leena Thomas, Susan T Hadman, Haydee B Romero
20 Jun 2011
21 CFR 1271.210(d)(2)
Verification elements
Cited by Leena Thomas, Susan T Hadman, Haydee B Romero
20 Jun 2011
21 CFR 1271.230(a)
Process validation procedures
Cited by Leena Thomas, Susan T Hadman, Haydee B Romero
20 Jun 2011
21 CFR 1271.230(a)
Validation & approval--established procedures
Cited by Leena Thomas, Susan T Hadman, Haydee B Romero
Investigators
FDA investigators tied to this site in the record.
Anthony N Onianwa2 insp.
Jonah S Ufferfilge1 insp.
Leena Thomas1 insp.
Susan T Hadman1 insp.
Haydee B Romero1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.200(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.210(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.210(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.270(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Westchester Medical Center Pathology Department's 1 Form 483
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