Aptinyx (Formally Naurex Inc.) – FDA Inspection, Jun 28, 2016

Record Details

This FDA Inspection record concerns Aptinyx (Formally Naurex Inc.), with an inspection on June 28, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Aptinyx (Formally Naurex Inc.)
Inspection Date: June 28, 2016
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · bf3e19bc-f396-44fe-801a-67142c31e9e0

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 985801
FDA center: Human Drugs
Project area: Bioresearch Monitoring

FDA Citations

21 CFR 312.50Ensuring compliance with plan and protocol
21 CFR 312.59Records of unused drug disposition

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FDA Inspection

Aptinyx (Formally Naurex Inc.)June 28, 2016