Prostrakan Inc. – FDA Inspection, Aug 3, 2010

Record Details

This FDA Inspection record concerns Prostrakan Inc., with an inspection on August 3, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Prostrakan Inc.
Inspection Date: August 3, 2010
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · 9a3dc5ae-91fa-4d1a-b4bd-069a84f7eec4

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 674356
FDA center: Human Drugs
Project area: Bioresearch Monitoring

FDA Citations

21 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report
21 CFR 310.305(c)Submission of report to incorrect office

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FDA Inspection

Prostrakan Inc.August 3, 2010