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FDA Inspection
•Constance Mao MD•April 14, 2014

Constance Mao MD – FDA Inspection, Apr 14, 2014

Record Details

This FDA Inspection record concerns Constance Mao MD, with an inspection on April 14, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Constance Mao MD
Inspection Date
April 14, 2014
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 516b9fdf-06d7-4c7a-84bc-d7f2f616d205

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
872545
FDA center
Biologics
Project area
Bioresearch Monitoring

FDA Citations

3
  1. 21 CFR 312.60FD-1572, protocol compliance
  2. 21 CFR 312.62(b)Case history records- inadequate or inadequate
  3. 21 CFR 50.27(a)Consent form not approved/signed/dated

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