Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-05-10.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 May 2017 – 10 May 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Mar 2014 – 25 Mar 2014 | Medical Devices & Rad Health | Clean | |
| 19 Nov 2012 | Not recorded | 483 | View 483 → |
| 30 Oct 2012 | Not recorded | Clean | |
| 4 May 2012 | Not recorded | 483 | View 483 → |
| 3 Sep 2009 | Not recorded | 483 | On file |
| 11 Jul 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Nov 2012
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Linda Linh T Nguyen
Investigators
FDA investigators tied to this site in the record.
Linda Linh T Nguyen2 insp.
Timothy C Grome2 insp.
Jude C Dike1 insp.
Karen D Phung1 insp.
Ruark Lanham1 insp.
Gary L Zaharek1 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 | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cardiva Medical, Inc.'s 4 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