Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-08.
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 |
|---|---|---|---|
| 5 Jan 2026 – 8 Jan 2026 | Medical Devices & Rad Health | Clean | |
| 13 Sep 2016 – 15 Sep 2016 | Medical Devices & Rad Health | Clean | |
| 16 Dec 2013 – 20 Dec 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Jan 2011 | Not recorded | 483 | View 483 → |
| 13 Jun 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Dec 2013
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Leighton K Ngai
20 Dec 2013
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Leighton K Ngai
Investigators
FDA investigators tied to this site in the record.
Jacey Roy1 insp.
Yuliana Hernandez-Magana1 insp.
Janet B Abt1 insp.
Leighton K Ngai1 insp.
Jeffrey R Wooley1 insp.
Connie L Hannon Rabel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Galt Medical Corporation'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