Overview
- 3 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
20 Jun 2025
21 CFR 58.31(f)
Management: personnel understand their functions
Cited by Hugh M Mcclure, Christine M Smith, Amanda M Szucsik
20 Jun 2025
21 CFR 58.35(b)(5)
QAU: authorize deviations from protocols or SOPs
Cited by Hugh M Mcclure, Christine M Smith, Amanda M Szucsik
20 Jun 2025
21 CFR 58.90(f)
Animal care: cage and equipment cleaning
Cited by Hugh M Mcclure, Christine M Smith, Amanda M Szucsik
Inspected site
NLNOBLE LIFE SCIENCES INC.Sykesville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.31(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.90(f) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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