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FDA Inspection
•Gabriel Perez Lasala, MD•March 31, 2011

Gabriel Perez Lasala, MD – FDA Inspection, Mar 31, 2011

Record Details

This FDA Inspection record concerns Gabriel Perez Lasala, MD, with an inspection on March 31, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Gabriel Perez Lasala, MD
Inspection Date
March 31, 2011
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 21bf60d3-667e-4aa3-9240-90d1ec37f17a

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
723216
FDA center
Biologics
Project area
Bioresearch Monitoring

FDA Citations

5
  1. 21 CFR 312.60FD-1572, protocol compliance
  2. 21 CFR 312.61Unauthorized recipients (investigator)
  3. 21 CFR 312.66Initial and continuing review
  4. 21 CFR 312.62(b)Case history records- inadequate or inadequate
  5. 21 CFR 50.20Consent not obtained, exceptions do not apply

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