Susan P. King-Harris, D.P.M. – FDA Inspection, May 9, 2019

Record Details

This FDA Inspection record concerns Susan P. King-Harris, D.P.M., with an inspection on May 9, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Susan P. King-Harris, D.P.M.
Inspection Date: May 9, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Andrace Deyampert (FDA Associated Person)

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ID · 1a64dda6-fb90-48ee-af34-6f00e1f27064

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 1089361
FDA center: Human Drugs
Project area: Bioresearch Monitoring
Outcome: Form 483 issued
Enforcement: Warning Letter

FDA Citations

21 CFR 312.60FD-1572, protocol compliance
21 CFR 312.56(a)Monitoring investigations
21 CFR 312.53(c)(1)Investigator statement (FDA 1572)
21 CFR 312.60Informed consent
21 CFR 312.62(b)Case history records- inadequate or inadequate
21 CFR 312.62(a)Accountability records
21 CFR 312.66Changes in research

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FDA Inspection

Susan P. King-Harris, D.P.M.May 9, 2019