From QSIT to CP 7382.850: How FDA Inspections Have Changed

On February 2, 2026, the FDA replaced the Quality System Inspection Technique (QSIT) with the Compliance Program 7382.850 as the new inspection framework for medical device manufacturers. For manufacturers, this means a different inspection approach, broader record review, and new expectations for demonstrating quality system effectiveness. 

Manufacturers should also be aware that documents previously excluded from routine FDA review, including management review, internal audit, and supplier audit records, are now within inspectional scope. At the same time, investigators are placing greater emphasis on quality system effectiveness and how risk is managed across the organization.

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Get your copy of the eBook to understand what has changed under CP 7382.850, what investigators are now looking for, and where your organization should focus its efforts to stay inspection-ready.

This eBook will help you:

  • check mark Understand the key differences between the QSIT inspection approach and Compliance Program 7382.850.
  • check mark Identify which records are nowmay now fall within the FDA inspectional scope and what that means for preparing for inspections readiness. 
  • check mark Navigate the different inspection modelsapproaches and understand what to expect based on your organization's inspection historyprofile. 
  • check mark Recognize the quality system deficiencies and risk management gaps that maycould lead to increased regulatory scrutiny.
qsit to cp