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CASE STUDIES

02

Regulatory QA - Fda recal audit confirmations (RAC)

Support FDA with Recall Audit Confirmations (RACs) and related compliance documentation/reporting

Context

  • FDA recall audit confirmation support program

  • Hybrid in-person and phone-based audit model

  • High-volume execution with 24-hour reporting requirement

  • Need for scalable, quality-controlled audit operations

Bracane Actions

  • Established governance, QC checks, and reporting cadence

  • Implemented JIT staffing and auditor training program

  • Centralized scheduling, documentation, and tracking

  • Deployed geographically dispersed audit teams

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Results

  • 1,500+ phone RACs and 300+ in-person visits completed (Task 1)

  • Additional 500+ phone RACs and 30+ visits (Task 2)

  • Built scalable national audit team model

  • Delivered consistent, inspection-ready reporting

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