Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-04-29.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Apr 2022 – 29 Apr 2022 | Biologics | 483 | View 483 → |
| 2 Aug 2021 – 18 Aug 2021 | Biologics | 483 | View 483 → |
| 18 Mar 2019 – 20 Mar 2019 | Human Drugs | Clean | |
| 17 Aug 2012 | 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.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.55(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.90(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.47(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.60(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 |
| 21 CFR 1271.85(d) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind St Luke's Hospital IRB's 2 Form 483s
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