FDA Inspection
Yvelice Villaman-BencosmeYvelice Villaman-Bencosme – FDA Inspection, Apr 28, 2017
Record Details
This FDA Inspection record concerns Yvelice Villaman-Bencosme, with an inspection on April 28, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 9fa81d01-806d-41b5-85bc-f117cb25fd6b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1010227
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
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