Wendy C. Daly, M.D. – FDA Inspection, Jul 1, 2019

Record Details

This FDA Inspection record concerns Wendy C. Daly, M.D., with an inspection on July 1, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company: Wendy C. Daly, M.D.
Inspection Date: July 1, 2019
Product Type: Biologics
Office: Center for Biologics Evaluation and Research
Person: Karen M. Cooper (Company Rep)

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ID · c61c4cc3-f463-47c5-8885-c4b850129737

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1094794
FDA center: Biologics
Project area: Bioresearch Monitoring
Outcome: Form 483 issued

FDA Citations

21 CFR 312.62(b)Case history records- inadequate or inadequate
21 CFR 312.64(b)Safety reports

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FDA Inspection

Wendy C. Daly, M.D.July 1, 2019