Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-24.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Sep 2025 – 24 Sep 2025 | Human Drugs | 483 | View 483 → |
| 29 Nov 2015 – 4 Dec 2015 | Human Drugs | 483 | View 483 → |
| 29 Jul 2015 – 3 Aug 2015 | Human Drugs | 483 | On file |
| 9 Jul 2014 – 11 Jul 2014 | Human Drugs | 483 | View 483 → |
| 15 Mar 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Dec 2015
21 CFR 212.10
Lack Adequate Resources, Facilities, Equipment.
Cited by Scott T Ballard, Matthew R Maddox
4 Dec 2015
21 CFR 212.10
Lack Adequate Resources, Facilities, Equipment.
Cited by Scott T Ballard, Matthew R Maddox
Investigators
FDA investigators tied to this site in the record.
Andrew Le1 insp.
Scott T Ballard1 insp.
Matthew R Maddox1 insp.
April L Young1 insp.
Ivan E Reyes1 insp.
Marie A Fadden1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.60(g)(3) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 212.71(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 212.10 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.20(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.50(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.20(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Mayo Clinic PET Radiochemistry Facility's 5 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