Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-10-18.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Oct 2023 – 18 Oct 2023 | Medical Devices & Rad Health | Clean | |
| 24 Feb 2020 – 27 Feb 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Sep 2016 – 3 Oct 2016 | Medical Devices & Rad Health | Clean | |
| 21 Jun 2016 – 23 Jun 2016 | Medical Devices & Rad Health | Clean | |
| 6 Apr 2015 – 14 Apr 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Jul 2014 – 11 Jul 2014 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Feb 2020
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Matthew M Vernon
27 Feb 2020
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Matthew M Vernon
14 Apr 2015
21 CFR 812.150(b)(7)
Sponsor final report for significant risk study
Cited by Thea C Grome, Timothy C Grome
Investigators
FDA investigators tied to this site in the record.
Christopher W Buser1 insp.
Matthew M Vernon1 insp.
Mark E Chan1 insp.
Adam S Freeman1 insp.
Thea C Grome1 insp.
Timothy C Grome1 insp.
Joseph A Seitz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 812.150(b)(7) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Silk Road Medical Inc's 2 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