Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-07-28.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Jul 2023 – 28 Jul 2023 | Medical Devices & Rad Health | Clean | |
| 25 Mar 2019 – 28 Mar 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Nov 2015 – 4 Dec 2015 | Medical Devices & Rad Health | 483 | On file |
| 14 Oct 2014 – 17 Oct 2014 | Medical Devices & Rad Health | Clean | |
| 6 Oct 2014 – 10 Oct 2014 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Oct 2014
21 CFR 820.30(g)
Design validation - software validation documentation
Cited by Ashleigh P Wodushek
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 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Myriad Genetics Laboratories, Inc.'s 3 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