Overview
- 24 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-01.
At a glance
Inspections
24
Form 483s
8
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Jul 2025 – 1 Aug 2025 | Biologics | 483 | View 483 → |
| 20 May 2025 – 22 May 2025 | Human Drugs | Clean | |
| 2 Mar 2023 – 10 Mar 2023 | Human Drugs | 483 | On file |
| 6 Sep 2021 – 10 Sep 2021 | Human Drugs | Clean | |
| 15 Sep 2020 – 16 Sep 2020 | Human Drugs | Clean | |
| 21 Jun 2018 – 29 Jun 2018 | Human Drugs | 483 | On file |
| 9 Apr 2018 – 12 Apr 2018 | Medical Devices & Rad Health | Clean | |
| 7 Nov 2016 – 11 Nov 2016 | Medical Devices & Rad Health | Clean | |
| 25 Apr 2016 – 29 Apr 2016 | Human Drugs | 483 | On file |
| 18 May 2015 – 20 May 2015 | Medical Devices & Rad Health | Clean | |
| 12 May 2014 – 16 May 2014 | Human Drugs | 483 | On file |
| 7 Aug 2013 – 14 Aug 2013 | Human Drugs | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Aug 2025
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Cody D Rickman, Mizanne E Lewis
1 Aug 2025
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Cody D Rickman, Mizanne E Lewis
Investigators
FDA investigators tied to this site in the record.
Michael Shanks2 insp.
Cody D Rickman1 insp.
Mizanne E Lewis1 insp.
MRA M BarbosaR1 insp.
MRA DavisM1 insp.
Marcus F Yambot1 insp.
Stephen C Smith1 insp.
Richard K Vogel1 insp.
Patric C Klotzbuecher1 insp.
Samuel K Gibbons1 insp.
Anita Narula1 insp.
Virgilio F Pacio1 insp.
Donald C Obenhuber1 insp.
Justine Tomasso1 insp.
Paul E Stein1 insp.
Reyes Candau-Chacon1 insp.
Bo Chi1 insp.
Ralph W Jerndal1 insp.
Helen B Ricalde1 insp.
Rodney D Combs1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Roche 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