Warning Letter Case Studies

At QualityHub, we have experience in warning letters for several types of companies and situations. Here are four examples of warning letter case studies to give you some background on that experience.

1. Third-Party Expert for Several Clients

Recidivist Warning Letter Case Study – 18-36 Months

  • Audited numerous sites several times for each client (baseline audits, mid-point audits and post-remediation audits)
  • Provided strategic consulting as needed (each project is different!)
  • Provided training and targeted consulting advice to workstreams

2. Third-Party Expert for Corporate

Corporate-Wide Warning Letter Case Study – 24+ Months

  • Performed a comprehensive management controls assessment (interviewed all senior staff and compiled a detailed report)
  • Met several times with FDA District Office, CDRH and Office of Enforcement
  • Audited 20+ sites and HQ twice for compliance (baseline and post-remediation)
  • Provided strategic consulting assistance with compliance master plan, and reviewed and commented on work being done by the workstreams
  • Trained 20+ sites and HQ on FDA readiness and trained senior management
  • Worked with company senior management on strategy
  • Worked with the client’s external FDA attorneys
  • Provided extensive training to senior management and to all sites
  • Provided coaching and site FDA inspection preparation training

3. Project Architect

Warning Letter Case Study – 14 Months

  • Created and managed compliance master plan
  • Provided subject matter experts for CMP workstreams
  • Provided associate-level consultants to support workstreams and day-to-day business operations
  • Rebuilt total quality system
  • Provided FDA readiness support including coaching and content development

4. Multi-Site

Warning Letter Case Study – 18+ Months

  • Performed quality system baseline audits (17 domestic & international sites) including detailed reports and project management services, cGMP audits, clinical audit, and good laboratory practices audit
  • Served as workstream SMEs on specific subsystems for an extended period of time following audit series
  • Provided acting/interim quality management system advisor who served as the corporate-level project architect for a company-wide remediation program
  • Provided associate consultant supporting the risk management system rebuild

Looking for more information about warning letters?