FDA’s Risk-Based Site Selection Model

digi — Mon, 02 Jun 2025 15:34:14 +0000

FDA’s Risk-Based Site Selection Model Understanding the FDA’s Risk-Based Site Selection Model for GMP Inspections The US Food and Drug Administration (FDA) employs a risk-based site selection model to determine which domestic and foreign pharmaceutical facilities should be inspected each year. This system prioritizes inspections based on product risk, compliance history, and other strategic factors...

FDA surveillance risk – Pharma GMP

FDA’s Risk-Based Site Selection Model