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.
4 Jun 2026
21 CFR 211.122(a)
Written procedures describing in detail
Cited by JeanClaude Garay, Chikitsa S Patel
4 Jun 2026
21 CFR 211.182
Written records kept in individual logs
Cited by JeanClaude Garay, Chikitsa S Patel
4 Jun 2026
21 CFR 211.192
Written record of investigation incomplete
Cited by JeanClaude Garay, Chikitsa S Patel
4 Jun 2026
21 CFR 211.194(a)(2)
Laboratory Test Method Verification
Cited by JeanClaude Garay, Chikitsa S Patel
4 Jun 2026
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by JeanClaude Garay, Chikitsa S Patel
Inspected site
NPNexus Pharmaceuticals, LLCLincolnshire, United States
Inspection team
CSChikitsa S Patel
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | 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