Overview
- 9 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-14.
At a glance
Inspections
9
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Jun 2024 – 14 Jun 2024 | Biologics | 483 | View 483 → |
| 29 Oct 2018 – 6 Nov 2018 | Biologics | 483 | On file |
| 19 Jan 2017 – 27 Jan 2017 | Biologics | 483 | On file |
| 16 Mar 2015 – 24 Mar 2015 | Biologics | 483 | On file |
| 1 Oct 2014 – 10 Oct 2014 | Biologics | 483 | On file |
| 2 Feb 2012 | Not recorded | 483 | On file |
| 23 Nov 2010 | Not recorded | 483 | On file |
| 20 Nov 2008 | Not recorded | 483 | On file |
| 3 Jul 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Jun 2024
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Cody D Rickman, Meihong Liu, Kaarin M Slotte, Kimberly M Bigler
14 Jun 2024
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Cody D Rickman, Meihong Liu, Kaarin M Slotte, Kimberly M Bigler
14 Jun 2024
21 CFR 820.40
Procedures not adequately established or maintained
Cited by Cody D Rickman, Meihong Liu, Kaarin M Slotte, Kimberly M Bigler
14 Jun 2024
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Cody D Rickman, Meihong Liu, Kaarin M Slotte, Kimberly M Bigler
14 Jun 2024
21 CFR 820.90(a)
Nonconforming product control
Cited by Cody D Rickman, Meihong Liu, Kaarin M Slotte, Kimberly M Bigler
Investigators
FDA investigators tied to this site in the record.
Cody D Rickman1 insp.
Meihong Liu1 insp.
Kaarin M Slotte1 insp.
Kimberly M Bigler1 insp.
Gene D Arcy1 insp.
Burnell M Henry1 insp.
Mihaly S Ligmond1 insp.
Omotunde O Osunsanmi1 insp.
Marion Michaelis1 insp.
Joyce A Rockwell1 insp.
Chad R Burger1 insp.
Paula A Trost1 insp.
Christian Lynch1 insp.
Cynthia Jim1 insp.
Prabhu P Raju1 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 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bio-Rad Medical Diagnostics GmbH's 8 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