Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-13.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Mar 2026 – 13 Mar 2026 | Human Drugs | 483 | View 483 → |
| 17 Mar 2025 – 20 Mar 2025 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Mar 2026
21 CFR 212.20(d)
Review of records for errors
Cited by Roger F Zabinski, Ronda R Loyd Jones
13 Mar 2026
21 CFR 212.20(e)
Written QA procedures established, followed
Cited by Roger F Zabinski, Ronda R Loyd Jones
13 Mar 2026
21 CFR 212.40(a)
Written procedures for control of components, containers, and closures
Cited by Roger F Zabinski, Ronda R Loyd Jones
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 212.20(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.20(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50(c)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Isorx Cyclotron Center'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