FDA Moves to Risk-Based Model for Biologics Facility Inspections

The Food and Drug Administration is again issuing a final rule amending its regulations on inspections of biologics facilities to remove a requirement that biologics facilities be inspected every two years so that FDA could instead follow more risk-based procedures. Instead, the timing of facility inspections will depend on the level of risk presented, FDA said. The final rule also removes FDA inspector duty requirements from the regulations altogether, as they are already outlined in the underlying statutes. FDA had issued the changes as an interim final rule in January 2018, before it had to withdraw it in May to respond to adverse comments. The final rule takes effect May 2.