Challenge: Understanding the Nuances of a Unique Warning Letter

Recidivist warning letters are unique. They’re so unique, in fact, that many companies don’t realize they can be issued even after a company feels like they have addressed a previous warning letter. If a company’s quality systems have ‘slippage’ in processes and product quality again, they become susceptible to receiving a recidivist warning letter (i.e., the FDA views them as repeat offenders). 

That was the case for one such QualityHub client, a major medical device company with over 20 sites globally. The Client struggled to adequately implement sustainable corrective actions from previous FDA warnings, and thus, was required to hire a third-party certifier (per the FDA) to monitor corrective actions before confirming remediation efforts with the FDA. They needed a reliable third-party certification team, one that also understood the ins and outs of effective remediation. Thanks to our longstanding rapport with the FDA, and expertise in resolving warning letters, QualityHub became the Client’s preferred partner.

Approach: Thorough Audits Leave ‘No Stone Unturned’

QualityHub performed comprehensive baseline audits for four of the Client’s sites — including the site that triggered the recidivist warning letter. Our baseline audits uncovered more deficiencies at each location than previously identified by the FDA. We documented everything and provided the Client with a highly detailed and itemized list of audit observations, which covered all areas of the quality system including Design Controls, Risk Management, Production and Process Controls, CAPA, Complaint Handling and MDR, and Supplier Controls. The Client then took our findings from the baseline audit and began assigning project managers, full-time employees, and temporary outsourced staff to address the many activities and deliverables attached to each finding and corrective action. 

From the baseline audit, we developed a three-round audit plan spanning two years. These verification audit rounds helped ensure that the FDA findings reported in the warning letter and the findings QualityHub noted in its baseline audits were adequately being contained and remediated. These verification audits required the Client to document any and all corrective actions applied to issues, including opening CAPAs to address the outstanding deficiencies. 

Results: Establishing Practices so Problems Don’t Return

The Client understood the gravity of the recidivist warning letter, and they invested considerable resources into getting each issue resolved. It took over a year from the date of the Client’s third-party certification and the FDA returning for a reinspection of their locations. For other companies, that year could lead to processes and procedures going back to square one. However, thanks to the Client’s cooperation, the FDA acknowledged that all issues had been remediated and that the recidivist warning letter had been resolved. The FDA’s approval of the Client also validated QualityHub’s position as one of the most thorough third-party certification groups.