Overview
- 20 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-08.
At a glance
Inspections
20
Form 483s
9
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Dec 2023 – 8 Dec 2023 | Biologics | 483 | View 483 → |
| 24 Jul 2019 – 31 Jul 2019 | Biologics | Clean | |
| 18 Jul 2017 – 24 Jul 2017 | Medical Devices & Rad Health | Clean | |
| 11 Jul 2017 – 19 Jul 2017 | Biologics | 483 | On file |
| 6 Jul 2016 – 13 Jul 2016 | Medical Devices & Rad Health | Clean | |
| 13 Jan 2015 – 29 Jan 2015 | Biologics | 483 | On file |
| 4 Nov 2013 – 8 Nov 2013 | Medical Devices & Rad Health | Clean | |
| 13 Dec 2012 | Not recorded | 483 | On file |
| 28 Aug 2012 | Not recorded | Clean | |
| 1 Nov 2011 | Not recorded | 483 | On file |
| 3 Mar 2011 | Not recorded | Clean | |
| 27 Jan 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Dec 2023
21 CFR 606.171
Biological product deviation report
Cited by Richard T Riggie, Christian Lynch, Nisha C Patel
8 Dec 2023
21 CFR 820.50(a)(1)
Evaluation and Selection, Suppliers, Contractors, etc.
Cited by Richard T Riggie, Christian Lynch, Nisha C Patel
20 Oct 2009
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by Amy M Cramer, Kinh Q Mac
20 Oct 2009
21 CFR 820.100(a)(4)
CAPA verification/validation of corrective/preventive action
Cited by Amy M Cramer, Kinh Q Mac
Investigators
FDA investigators tied to this site in the record.
Kinh Q Mac4 insp.
Amy M Cramer3 insp.
Loretta Nemchik2 insp.
Prabhu P Raju2 insp.
Richard T Riggie1 insp.
Christian Lynch1 insp.
Nisha C Patel1 insp.
Sarah M Forney1 insp.
Burnell M Henry1 insp.
Guang Gao1 insp.
Simone E Pitts1 insp.
Susan M Jackson1 insp.
Jacqueline M Diaz Albert1 insp.
Eric J Cunningham1 insp.
Helen B Ricalde1 insp.
Atul Agrawal1 insp.
Lauren L Vajo1 insp.
Rose M Ashley1 insp.
Frank J Marciniak1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Roche Molecular Systems, Inc.'s 9 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