FDA Inspection
First All-Med IRBFirst All-Med IRB – FDA Inspection, Aug 5, 2026
Record Details
This FDA Inspection record concerns First All-Med IRB, with an inspection on August 5, 2026, issued by the Philadelphia District Office, covering medical devices & rad health.
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ID · 55696dea-0b30-430c-8740-3c004fd59c96
Inspection Facts
- Inspection number
- 1325612
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 50.25(c)ClincialTrials.gov statement
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 56.108(a)(3)Prompt reporting of changes
- 21 CFR 56.108(a)(4)Changes in approved research
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
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