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.
21 Mar 2025
21 CFR 58.185(a)(6)
Final report: description of methods
Cited by Samson O Oluseye, Audrey J Yarbrough
21 Mar 2025
21 CFR 58.185(a)(7)
Final report: description of test system
Cited by Samson O Oluseye, Audrey J Yarbrough
21 Mar 2025
21 CFR 58.33(b)
Study director: all data recorded and verified
Cited by Samson O Oluseye, Audrey J Yarbrough
Inspected site
CRCharles River Laboratories, Inc.Reno, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.120(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(b) | 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