Mark A. Stein, Ph.D. – FDA Inspection, Aug 4, 2023

Record Details

This FDA Inspection record concerns Mark A. Stein, Ph.D., with an inspection on August 4, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Mark A. Stein, Ph.D.
Inspection Date: August 4, 2023
Product Type: Drugs
Office: Center for Drug Evaluation and Research
People: Sherri N. Rohlf (Company Rep)
Veronica L. Bush (Issuing Officer)

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ID · db397397-c298-416c-97cc-b5f56ac77a45

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 1211589
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
21 CFR 312.60FD-1572, protocol compliance
21 CFR 312.60FD-1572, protocol compliance
21 CFR 312.62(b)Case history records- inadequate or inadequate

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FDA Inspection

Mark A. Stein, Ph.D.August 4, 2023