Odonate Therapeutics, Inc. – FDA Inspection, Sep 10, 2018

Record Details

This FDA Inspection record concerns Odonate Therapeutics, Inc., with an inspection on September 10, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Odonate Therapeutics, Inc.
Inspection Date: September 10, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Lakecha N. Lewis (FDA Associated Person)

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ID · 062d5937-b01a-4ed3-af47-c3d80ca15b5b

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1065084
FDA center: Human Drugs
Project area: Bioresearch Monitoring
Outcome: Form 483 issued

FDA Citations

21 CFR 312.50Ensuring compliance with plan and protocol
21 CFR 312.52(a)Transfer of obligations

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FDA Inspection

Odonate Therapeutics, Inc.September 10, 2018