Balamurali K. Ambati , M.D., Ph.D. – FDA Inspection, Apr 4, 2019

Record Details

This FDA Inspection record concerns Balamurali K. Ambati , M.D., Ph.D., with an inspection on April 4, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Balamurali K. Ambati , M.D., Ph.D.
Inspection Date: April 4, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Julian C. Hanson (Issuing Officer)

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ID · 2d9afe58-a72b-4780-9631-b2448f259b9d

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 1085546
FDA center: Human Drugs
Project area: Bioresearch Monitoring
Outcome: Form 483 issued
Enforcement: Warning Letter

FDA Citations

21 CFR 312.20(a)Failure to submit an IND

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FDA Inspection

Balamurali K. Ambati , M.D., Ph.D.April 4, 2019