Overview
- 11 public-safe observations are available for this inspection.
- 11 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.
22 May 2026
21 CFR 58.120(a)
Protocol: approved
Cited by Erin M Mcdowell, Courtney R Bratina, Audrey J Yarbrough
22 May 2026
21 CFR 58.120(b)
Protocol: approval of changes
Cited by Erin M Mcdowell, Courtney R Bratina, Audrey J Yarbrough
22 May 2026
21 CFR 58.185(a)(2)
Final report: objectives, procedures, changes
Cited by Erin M Mcdowell, Courtney R Bratina, Audrey J Yarbrough
22 May 2026
21 CFR 58.185(a)(9)
Final report: circumstances affecting data qual., integrity
Cited by Erin M Mcdowell, Courtney R Bratina, Audrey J Yarbrough
22 May 2026
21 CFR 58.185(c)
Final report: corrections or additions
Cited by Erin M Mcdowell, Courtney R Bratina, Audrey J Yarbrough
Inspected site
IPIbex Preclinical Research, Inc.Logan, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.120(a) | 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)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(a) | 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(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.81(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 11 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