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  4. FDA’s Risk-Based Approach to Inspections
  1. Inspection Basics

FDA’s Risk-Based Approach to Inspections

The FDA uses a risk-based evaluation to select foreign and domestic medical product manufacturing facilities for inspection The agency prioritizes medical product surveillance inspections deemed high-risk based on a variety of specific criteria, such as:  

  • facility type, such as manufacturer, control laboratory, etc.
  • the facility’s compliance history, including whether it has been inspected in the last four years
  • hazard signals, including the record of signals, history and nature of product recalls linked to the facility, etc.
  • inherent risks of the product manufactured at a facility, such as dosage form, route of administration, products intended to be sterile, concentration of active pharmaceutical ingredient in dosage form, emergency use, etc.
  • whether the facility has been inspected by a foreign regulatory partner

For example, a sterile drug manufacturing site that has not been previously inspected and is making narrow therapeutic index drugs would likely be deemed a higher risk than a site that had a well-known inspectional and compliance history that is making over-the-counter solid oral dosage form drugs. 

For bioresearch monitoring (clinical and non-clinical research) inspections, the agency considers several risk-based factors, including:

  • compliance history
  • complaints associated with the site
  • number of applications the site is associated with
  • enrollment numbers
  • number of protocol exceptions/deviations
  • data anomalies

Human and animal food inspections are driven by the Food Safety Modernization Act inspection frequency mandate that requires domestic high-risk facilities to be inspected every three years and non-high-risk facilities are inspected every five years. 

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