Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-04-10.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Apr 2023 – 10 Apr 2023 | Medical Devices & Rad Health | Clean | |
| 1 Mar 2016 – 4 Mar 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Feb 2013 – 14 Feb 2013 | Medical Devices & Rad Health | Clean | |
| 15 Jun 2010 | Not recorded | 483 | On file |
| 6 Feb 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Mar 2016
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Lydia S Chan
4 Mar 2016
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Lydia S Chan
Investigators
FDA investigators tied to this site in the record.
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 |
Full site report
Get the verbatim findings behind BioCardia, Inc.'s 2 Form 483s
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