Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
22 May 2026
21 CFR 212.10
Personnel not qualified
Cited by Linda Thai, Sateesh Kum Sathigari, Cecilia H Kieu, Anney Lin
22 May 2026
21 CFR 212.30(b)
Equipment procedures
Cited by Linda Thai, Sateesh Kum Sathigari, Cecilia H Kieu, Anney Lin
22 May 2026
21 CFR 212.40(c)
Use of reliable suppliers
Cited by Linda Thai, Sateesh Kum Sathigari, Cecilia H Kieu, Anney Lin
22 May 2026
21 CFR 212.50(b)(6)
Action limits on radiochemical yield
Cited by Linda Thai, Sateesh Kum Sathigari, Cecilia H Kieu, Anney Lin
22 May 2026
21 CFR 212.70(c)
Conform to specs prior to release, either the drug product, sub-batch, or both
Cited by Linda Thai, Sateesh Kum Sathigari, Cecilia H Kieu, Anney Lin
Inspected site
PSPETNET SOLUTIONS, INCSan Diego, 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 212.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.40(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.70(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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