What are four different types of FDA audits?

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1173873

2026-04-07 18:05

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The FDA conducts several types of audits, including:

  1. Pre-Approval Inspections (PAIs) to evaluate facilities before drug approvals.
  2. Routine Inspections to assess compliance with Good Manufacturing Practices (GMP).
  3. For-Cause Inspections triggered by specific issues or complaints regarding a facility or product.
  4. Bioresearch Monitoring Inspections to review compliance in clinical trials and research activities.

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