Overview
- 4 public-safe observations are available for this inspection.
- 4 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 Apr 2018
21 CFR 58.105(d)
Test article: reserve sample retention
Cited by Nicole C Victoria, Kellie L Thommes
13 Apr 2018
21 CFR 58.31(f)
Management: personnel understand their functions
Cited by Nicole C Victoria, Kellie L Thommes
13 Apr 2018
21 CFR 58.33(e)
Study director: follow GLP regulations
Cited by Nicole C Victoria, Kellie L Thommes
Inspected site
APAmerican Preclinical ServicesMinneapolis, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.105(d) | 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(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(a) | 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 4 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