Mock FDA Inspection

SITUATION

An innovative biopharmaceutical company focused on development and commercialization of medicines to treat renal diseases were in need of an urgent mock Food and Drug Administration (FDA) inspection. They had recently laid off most of their Clinical Operations team; however, they were expecting an FDA inspection after filing a supplemental New Drug Application (sNDA).

SOLUTION

  • Halloran assembled a team of consultants seasoned in FDA interactions to prepare for and conduct a 3-day mock FDA inspection within the client’s 2-week timeframe.
  • Halloran developed specialized inspection checklists to conduct a comprehensive mock inspection, reviewing the same topics that would be reviewed by an FDA inspector through the Bioresearch Monitoring (BIMO) method.
  • Halloran took a consultative approach toward the mock inspection through the requested “hats on, hats off” method, in which the mock inspectors held debrief meetings at the conclusion of each inspection day to highlight successes as well as key observations. 
  • Halloran delivered a mock Establishment Inspection Report and FDA Form 483 following the inspection.
  • Halloran prioritized all observations and provided remediation plans specific to each observation.

VALUE

The Company received detailed observations through the identification of key gaps in documentation, processes, and inspection behavior. Remediation plans for each of their key observations were provided after the delivery of mock inspection observations. The Company subsequently asked Halloran to assist with the remediation tasks, develop storyboards, and conduct inspection readiness behavioral coaching sessions with their key subject matter experts.