PSG Institute of Medical Science and Research – FDA Inspection, Nov 10, 2016

Record Details

This FDA Inspection record concerns PSG Institute of Medical Science and Research, with an inspection on November 10, 2016, issued by the Office of Inspections and Investigations, covering human drugs.

Company: PSG Institute of Medical Science and Research
Inspection Date: November 10, 2016
Product Type: Human Drugs
Office: Office of Inspections and Investigations
Person: Karen L. Kosar (FDA Associated Person)

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ID · 28c8f0b0-947a-45ef-b4d4-5c4654bafc30

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 994766
FDA center: Human Drugs
Project area: Bioresearch Monitoring
Outcome: Form 483 issued

FDA Citations

21 CFR 312.62(b)Case history records- inadequate or inadequate

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FDA Inspection

PSG Institute of Medical Science and ResearchNovember 10, 2016