Second Case Study for C-level Professionals

In 2011, FDA issued three 483s to three separate divisions of a device manufacturer. Fearing a Warning Letter or corporate-wide regulatory action, the company scrambled resources to address the findings and avoid escalation of enforcement action. Among the quality system elements cited by FDA were process validation remediation requirements, especially for legacy products. This was a recurring theme across all of the 483s, leading to additional speculation and concern about the Agency’s next steps. The manufacturer believed that if they could implement a compliance plan including corrections, corrective actions and preventive actions, they may be able to hold additional FDA action at bay – but they had to move quickly. One of their first actions was to set a monthly meeting with regulators to demonstrate progress and commitment to the compliance plan. Their next move was to divert all R&D resources to work on the compliance initiative. Management’s thinking was that this redirection of resources would be low-cost, as the resources were already on the payroll, and that it would keep the acquired knowledge in-house. Unfortunately, as of the first monthly report, there wasn’t a lot of progress to report to FDA. Management left the meeting feeling disheartened that the Agency might take the reins of the remediation activities away from them, resulting in a loss of control of the spend rate and remediation approach. To make matters worse, the R&D director reported that the re-assignment of resources away from product development would have a measurable impact on the company’s future revenue stream and stifle competitive advantages as competitors released new technologies ahead of them. Fortunately, a director in one of the strategy meetings had worked with GCI when his previous company was under a Corporate Warning Letter, and he suggested it was time to call GCI.

We work with companies concerned with the loss of control of the spend rate associated with compliance actions under the thumb of regulatory agencies. We were able to quickly deploy Balanced Teams of engineers to multiple manufacturing sites to gain traction on the remediation activities. GCI’s prudent implementation of checklists and templates, under the direction of a third-party, former FDA inspector hired by the manufacturer, enabled them to report significant progress to the Agency at their next meeting, and ultimately to retain control of the spend rate and scope of the remediation activities. By making our employee engineers available to the company for hire at the end of the project, the manufacturer retained the knowledge in house. As an added bonus, the return of the re-assigned R&D team to their regular posts ensured that new products would continue to be commercialized and protect the company’s investment in the life sciences industry for years to come.