FDA Inspection
Ibex Preclinical Research, Inc.Ibex Preclinical Research, Inc. – FDA Inspection, May 22, 2026
Record Details
This FDA Inspection record concerns Ibex Preclinical Research, Inc., with an inspection on May 22, 2026, issued by the Denver District Office, covering human drugs.
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ID · 1f3cffe5-8f9d-49d5-beaf-16dd15fe44a9
Inspection Facts
- Inspection number
- 1318936
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 58.120(a)Protocol: approved
- 21 CFR 58.120(b)Protocol: approval of changes
- 21 CFR 58.185(a)(2)Final report: objectives, procedures, changes
- 21 CFR 58.185(a)(9)Final report: circumstances affecting data qual., integrity
- 21 CFR 58.185(c)Final report: corrections or additions
- 21 CFR 58.33(a)Study director: follow study protocol
- 21 CFR 58.33(b)Study director: all data recorded and verified
- 21 CFR 58.33(f)Study director: transfer of data to archives
- 21 CFR 58.35(b)(1)QAU: maintain a master schedule
- 21 CFR 58.35(b)(7)QAU: signed statement in final report
Showing 10 of 11 citations.
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Other FDA inspections of Ibex Preclinical Research, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2018 | Not classified | Denver District Office |
Other documents for Ibex Preclinical Research, Inc.
- FDA Inspection 1044576 - 2018-01-25
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