FDA Inspection
Julia C. Carnevale, M.D.Julia C. Carnevale, M.D. – FDA Inspection, Dec 12, 2024
Record Details
This FDA Inspection record concerns Julia C. Carnevale, M.D., with an inspection on December 12, 2024, issued by the San Francisco District Office, covering biologics.
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ID · 5489094a-0d44-4d51-b961-ae43c5fcc5b4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1256432
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 50.27(b)(2)Short form: Oral presentation/signing
- 21 CFR 312.64(b)Safety Reports - Non-Serious Events
- 21 CFR 312.64(b)Safety Reports - Serious Events
- 21 CFR 50.25(a)(6)Compensation, medical treatment in event of injury
- 21 CFR 312.66Changes in research
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
- 21 CFR 50.25(a)(1)Statement of research, purpose, duration of participation
- 21 CFR 50.25(a)(8)Participation; refusal and discontinuance
- 21 CFR 50.25(c)ClincialTrials.gov statement
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