FDA Inspection
Dr. Constance M. Westhoff @ NYBCDr. Constance M. Westhoff @ NYBC – FDA Inspection, Sep 12, 2013
Record Details
This FDA Inspection record concerns Dr. Constance M. Westhoff @ NYBC, with an inspection on September 12, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 12, 2013
- Product Type
- Biologics
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ID · ee9a2c96-5063-4318-87e5-34c2a1fa44d4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 845896
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(4)Investigator protocol records inadequate
- 21 CFR 812.140(a)(5)Additional investigator records FDA requires
- 21 CFR 812.140(b)(3)Sponsor records of investigator agreements inadequate
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