Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
ICIsorx Cyclotron CenterLubbock, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.20(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.20(e) | 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(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 |
Full 483 report
Get the verbatim text of all 7 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere