Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-26.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Mar 2026 – 26 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Jun 2023 – 14 Jun 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Sep 2018 – 21 Sep 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Sep 2014 – 18 Sep 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Nov 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Mar 2026
ISO 13485:2016 Clause 4.1.5
External party controls do not include written quality agreements
Cited by Yuliana Hernandez-Magana
14 Jun 2023
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by Jocelyn C Turner
14 Jun 2023
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Jocelyn C Turner
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 820.70(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.17(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.5 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Footprint 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