Resolving a Corporate Warning Letter and Laying New Groundwork

Challenge: Compounding Issues Come to a Head

A global leader in cardiovascular health (henceforth known as the Client) 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, a corporate warning letter could financially harm the company. 

The Client’s inexperience with such a rare occurrence left them struggling to develop a corporate-wide strategy. They also lacked the FDA knowledge required to properly implement a multifaceted series of changes to get the corporate warning letter removed. Time was of the essence; waiting longer would put them further behind in sales and product development. The Client reached out to QualityHub for a large-scale intensive approach to revamp policies, processes, training, and compliance. 

Approach: Assessment and Collaboration

To get started, QualityHub took an extensive look into the company, both from a corporate perspective and also at each location across the globe. We applied our fact-driven, evidence- based reporting to one of the most comprehensive series of audits ever conducted.

First, QualityHub performed an extensive management controls assessment. The team interviewed all senior staff and compiled a detailed report to inform next steps. 

Cooperation and communication are critical to resolving any warning letter — especially one as serious as corporate warning letters. Knowing this, we worked alongside the Client’s external FDA attorneys. The Client invested in multi-site training, and QualityHub trained over 20 international sites and Company HQ on FDA readiness. QualityHub also tailored training to senior management across those sites. Rather than create a plan in a vacuum, QualityHub worked alongside senior management on implementation strategy. Throughout the process, QualityHub met several times with the FDA District Office, CDRH and the Office of Enforcement. This kept everyone informed and engaged during the process. 

Given our experience alongside the FDA, we took an FDA-based approach to every step of the process. This meant that the plan was developed with longstanding FDA compliance in mind, and our experts could accurately inform the company as to how long the warning letter remediation process would take to fulfill FDA requirements. 

Results: Regaining Compliance after a Warning Letter

Using our process, expertise and timelines, we were able to get the corporate warning letter lifted. QualityHub also achieved the Client’s biggest priority: getting back into the marketplace in a compliant manner. QualityHub equipped the Client with processes made to last, and they were scalable enough to support the rapid growth the Client had prior to receiving the corporate warning letter.