Overview
- 10 public-safe observations are available for this inspection.
- 5 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.
28 Jun 2018
21 CFR 58.130(e)
Conduct: changes in automated data entries
Cited by Mark J Seaton, Corey K Reno
28 Jun 2018
21 CFR 58.185(a)(9)
Final report: circumstances affecting data qual., integrity
Cited by Mark J Seaton, Corey K Reno
28 Jun 2018
21 CFR 58.33(b)
Study director: all data recorded and verified
Cited by Mark J Seaton, Corey K Reno
28 Jun 2018
21 CFR 58.35(b)(5)
QAU: authorize deviations from protocols or SOPs
Cited by Mark J Seaton, Corey K Reno
Inspected site
CRCharles River LaboratoriesMattawan, United States
Inspection team
CKCorey K Reno
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.130(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.185(a)(9) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.33(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.35(b)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.41 | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 10 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