Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-10.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jun 2026 – 10 Jun 2026 | Medical Devices & Rad Health | Clean | |
| 14 Aug 2023 – 17 Aug 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Oct 2019 – 17 Oct 2019 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Aug 2023
21 CFR 803.17(a)(1)
Lack of System for Event Evaluations
Cited by Karen M Rodriguez, Karen M Cruz Arenas
17 Aug 2023
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Karen M Rodriguez, Karen M Cruz Arenas
17 Aug 2023
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Karen M Rodriguez, Karen M Cruz Arenas
17 Aug 2023
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Karen M Rodriguez, Karen M Cruz Arenas
Investigators
FDA investigators tied to this site in the record.
Alex J Wild1 insp.
Pascal G Felix1 insp.
Karen M Rodriguez1 insp.
Karen M Cruz Arenas1 insp.
Joshua J Silvestri1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.17 | 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(j) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Myriad Medical, LLC's 2 Form 483s
Source PDFs 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