FDA Inspection
Namita A. Goyal, M.D.Namita A. Goyal, M.D. – FDA Inspection, Jun 23, 2023
Record Details
This FDA Inspection record concerns Namita A. Goyal, M.D., with an inspection on June 23, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · c785c899-f970-45a9-88e3-b20a1a7ab79e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1209328
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 50.20Consent not obtained, exceptions do not apply
- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.64(b)Safety Reports - Serious Events
- 21 CFR 312.66Changes in research
- 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 - Serious Events
- 21 CFR 312.66Changes in research
- 21 CFR 50.20Consent not obtained, exceptions do not apply
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