Tuesday, February 24, 2009

Top Reasons for FDA inspection

  1. Routine Inspections, Routine Surveillance, For Cause inspections
  2. Pre-approval and Post-approval
  3. Controlling product approvals for commercialization
  4. Surveillance Programs through Adverse event reports
  5. Undercover Surveillance (drug/device promotion, distribution)
  6. Consumer complaints/former employee complaints (Whistle-blower)
  7. Bioresearch Monitoring Foreign
  8. Benchmarking, Complaints and Recall related
  9. New Product/Process Being Implemented

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