Overview
- 19 public-safe observations are available for this inspection.
- 19 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.
10 Sep 2019
21 CFR 58.10
Notifying contractor of GLP status
Cited by Nicole C Victoria, Eric S Myskowski
10 Sep 2019
21 CFR 58.105(c)
Test article: storage container labeling
Cited by Nicole C Victoria, Eric S Myskowski
10 Sep 2019
21 CFR 58.105(d)
Test article: reserve sample retention
Cited by Nicole C Victoria, Eric S Myskowski
10 Sep 2019
21 CFR 58.120(a)(11)
Protocol: date and signature
Cited by Nicole C Victoria, Eric S Myskowski
Inspected site
NANorth American Science Associates, LLCSaint Paul, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.105(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.105(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.120(a)(11) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.120(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.120(a)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.190(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.190(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.63(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.83 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.90(g) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 19 observations
The source PDF, 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