Henry, W. Keith, M.D., Clinical Investigator – FDA Inspection, Sep 19, 2018

Record Details

This FDA Inspection record concerns Henry, W. Keith, M.D., Clinical Investigator, with an inspection on September 19, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Henry, W. Keith, M.D., Clinical Investigator
Inspection Date: September 19, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Sharon L. Matson (FDA Associated Person)

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ID · 39275422-6fa5-44f1-a2f5-1857d6b86566

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1066126
FDA center: Human Drugs
Project area: Bioresearch Monitoring
Outcome: Form 483 issued

FDA Citations

21 CFR 312.60FD-1572, protocol compliance

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FDA Inspection

Henry, W. Keith, M.D., Clinical InvestigatorSeptember 19, 2018