FDA Inspection
Vincent A. RestivoVincent A. Restivo – FDA Inspection, May 26, 2023
Record Details
This FDA Inspection record concerns Vincent A. Restivo, with an inspection on May 26, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 64d62502-739e-4245-9825-9a63eeb4a84e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1207133
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.64(b)Safety Reports - Non-Serious Events
- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.64(b)Safety Reports - Non-Serious Events
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