Overview
- 6 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-02-21.
At a glance
Inspections
6
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Feb 2025 – 21 Feb 2025 | Human Drugs | 483 | View 483 → |
| 11 Sep 2023 – 14 Sep 2023 | Medical Devices & Rad Health | Clean | |
| 30 Jan 2020 – 4 Feb 2020 | Human Drugs | Clean | |
| 19 Jun 2017 – 23 Jun 2017 | Human Drugs | Clean | |
| 9 Jun 2015 – 18 Jun 2015 | Human Drugs | Clean | |
| 24 Feb 2014 – 28 Feb 2014 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Feb 2025
21 CFR 211.110(a)
Written in-process control procedures
Cited by Ucheabuchi C Chudi-Nwankwor
21 Feb 2025
FDCA 582(b)(4)
Systems in place to comply with verification requirements
Cited by Ucheabuchi C Chudi-Nwankwor
Investigators
FDA investigators tied to this site in the record.
Ucheabuchi C Chudi-Nwankwor1 insp.
Talmane J Fisher1 insp.
Jon P Antoniou1 insp.
Logan T Williams1 insp.
Michael P Sheehan1 insp.
Lindsey M Schwierjohann1 insp.
Tracey L Harris1 insp.
Christine E Kelley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Summit Biosciences Inc.'s 1 Form 483
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