Case Study: Warning Letter

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.

Resolving a Corporate Warning Letter

Corporate-Wide Warning Letter – 24+ Months

A global leader in cardiovascular health reached out to QualityHub with a critical and unique need. Numerous product recalls, multiple failed site inspections, and disjointed quality procedures culminated in the Client receiving a corporate warning letter from the FDA. This corporate warning letter included hundreds of action items needing to be addressed. While the warning letter itself was problematic, the loss of time spent in market and possible court involvement compounded the problems. The Client understood this was a time-intensive and labor-intensive process, but if left unaddressed…  Read the full case study here.

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

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


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 rebuildReso

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