FDA Inspection
Ponce Medical School Foundation, Inc. IRBPonce Medical School Foundation, Inc. IRB – FDA Inspection, Feb 24, 2023
Record Details
This FDA Inspection record concerns Ponce Medical School Foundation, Inc. IRB, with an inspection on February 24, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 70ae53cd-ebd6-4ce0-9877-707933026437
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1198493
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.109(e)IRB approvals/disapprovals - general
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(a)(5)List of members
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Other FDA inspections of Ponce Medical School Foundation, Inc. IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 20, 2011 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Ponce Medical School Foundation, Inc. IRB
- FDA Inspection 730607 - 2011-06-20
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