Overview
- 14 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-31.
At a glance
Inspections
14
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jan 2025 – 31 Jan 2025 | Biologics | 483 | View 483 → |
| 2 Aug 2023 – 3 Aug 2023 | Medical Devices & Rad Health | Clean | |
| 7 Dec 2021 – 13 Dec 2021 | Biologics | 483 | View 483 → |
| 8 Oct 2019 – 21 Oct 2019 | Biologics | 483 | View 483 → |
| 30 Jul 2018 – 9 Aug 2018 | Biologics | 483 | On file |
| 23 May 2017 – 26 May 2017 | Medical Devices & Rad Health | Clean | |
| 14 Jun 2016 – 21 Jun 2016 | Biologics | Clean | |
| 17 Apr 2014 – 23 Apr 2014 | Biologics | 483 | On file |
| 21 Nov 2013 – 26 Nov 2013 | Medical Devices & Rad Health | Clean | |
| 31 Jan 2012 | Not recorded | 483 | On file |
| 18 Nov 2011 | Not recorded | Clean | |
| 3 Sep 2010 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Oct 2019
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Mihaly S Ligmond
21 Oct 2019
21 CFR 820.70(g)(1)
Maintenance schedule, Lack of or inadequate schedule
Cited by Mihaly S Ligmond
Investigators
FDA investigators tied to this site in the record.
Prabhu P Raju3 insp.
Creighton T Tuzon1 insp.
Kaarin M Slotte1 insp.
Stephen R Souza1 insp.
Lewis K Antwi1 insp.
Mihaly S Ligmond1 insp.
Arie Menachem1 insp.
Paul M Kawamoto1 insp.
Gene D Arcy1 insp.
Burnell M Henry1 insp.
Sharon I Gundersen1 insp.
Xiaojun Yan1 insp.
Bryce E Mansfield1 insp.
Catherine J Laufmann1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bio-Rad Laboratories, Inc.'s 6 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