Overview
- 23 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-20.
At a glance
Inspections
23
Form 483s
8
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Mar 2024 – 20 Mar 2024 | Human Drugs | 483 | On file |
| 10 Jul 2023 – 14 Jul 2023 | Human Drugs | 483 | On file |
| 26 Oct 2021 – 29 Oct 2021 | Human Drugs | Clean | |
| 26 Aug 2019 – 29 Aug 2019 | Medical Devices & Rad Health | 483 | On file |
| 11 Jun 2018 – 19 Jun 2018 | Human Drugs | 483 | View 483 → |
| 16 Apr 2018 – 19 Apr 2018 | Medical Devices & Rad Health | Clean | |
| 14 Nov 2016 – 18 Nov 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Aug 2016 – 9 Aug 2016 | Human Drugs | Clean | |
| 14 Apr 2016 – 22 Apr 2016 | Human Drugs | Clean | |
| 11 Apr 2016 – 14 Apr 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 May 2015 – 27 May 2015 | Medical Devices & Rad Health | Clean | |
| 27 Mar 2014 – 4 Apr 2014 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Ralph W Jerndal2 insp.
Richard Ledwidge1 insp.
Michael Shanks1 insp.
MRA DavisM1 insp.
Matthew D Schnittker1 insp.
Marcus F Yambot1 insp.
Stephen C Smith1 insp.
Richard K Vogel1 insp.
Zhihao Pete Qiu1 insp.
Zhong Li1 insp.
Joey V Quitania1 insp.
David J Gomes1 insp.
Kimberly Lewandowski-Walker1 insp.
Samuel K Gibbons1 insp.
Seneca D Toms1 insp.
Xiaokuang Lai1 insp.
Rosanna M Goodrich1 insp.
Paul E Stein1 insp.
Prabhu P Raju1 insp.
Rodney D Combs1 insp.
Shirley J Berryman1 insp.
Neal L Adams1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(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, verbatim observations, 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