Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-16.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 May 2025 – 16 May 2025 | Biologics | 483 | View 483 → |
| 27 Feb 2023 – 7 Mar 2023 | Biologics | 483 | View 483 → |
| 28 Nov 2016 – 1 Dec 2016 | Medical Devices & Rad Health | Clean | |
| 3 Feb 2014 – 6 Feb 2014 | Medical Devices & Rad Health | 483 | On file |
| 6 Aug 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 May 2025
21 CFR 820.75(c)
Documentation - review in response to changes or deviations
Cited by Celeta S Coves, Kaarin M Slotte
7 Mar 2023
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Richard T Riggie, Gene D Arcy, Meihong Liu, Elias N Paz Alonzo
7 Mar 2023
21 CFR 820.70(a)
Production processes
Cited by Richard T Riggie, Gene D Arcy, Meihong Liu, Elias N Paz Alonzo
7 Mar 2023
21 CFR 820.80(e)
Documentation
Cited by Richard T Riggie, Gene D Arcy, Meihong Liu, Elias N Paz Alonzo
Investigators
FDA investigators tied to this site in the record.
Celeta S Coves1 insp.
Kaarin M Slotte1 insp.
Richard T Riggie1 insp.
Gene D Arcy1 insp.
Meihong Liu1 insp.
Elias N Paz Alonzo1 insp.
James W Whitney1 insp.
Amy M Cramer1 insp.
Natasha N Mccants1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bio-Rad's 3 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