Ernest F Bizjak
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Detailed Analysis
Ernest F Bizjak adopts a by-the-book approach, meticulously examining compounded drug products, prescriptions, and labeling to ensure strict compliance with FDCA regulations. He prioritizes thorough documentation and evidence of CGMP adherence.
Ernest F Bizjak is a detail-oriented FDA auditor who focuses on compliance with FDCA regulations, particularly in the area of compounded drug products. He emphasizes the need for valid prescriptions for individually-identified patients and is strict about adherence to FDA approval requirements, labeling directions, and CGMP.
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