Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-26.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Aug 2025 – 26 Aug 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Jun 2021 – 22 Jun 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Oct 2019 – 21 Oct 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 May 2017 – 29 Jun 2017 | Medical Devices & Rad Health | WL | View 483 → |
| 24 Jun 2014 – 25 Jun 2014 | Medical Devices & Rad Health | Clean | |
| 9 Mar 2011 | Not recorded | Clean | |
| 16 Jun 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Aug 2025
21 CFR 806.10(a)(2)
Report of violation of the Act (see 803.52(e)(9))
Cited by Sunita Pandey
Investigators
FDA investigators tied to this site in the record.
Sara M Onyango2 insp.
James W Whitney2 insp.
Sunita Pandey1 insp.
Suzanne M Healy1 insp.
Ian A Pilcher1 insp.
Jonathan B Lewis1 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 | 13x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 806.10(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Magellan Diagnostics, 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