Challenge: Unique and Unsolved Problems from Existing Consent Decree

Consent decrees, when left unaddressed, can quickly escalate into additional costly penalties such as removal of product from market, injunction, increased litigation, liquidated damages, criminal prosecution, etc. . However, when these decrees are resolved correctly, companies can avoid further issues with the FDA and other regulatory agencies.

A leading medical device manufacturer (henceforth known as the Client) needed to meet consent decree requirements after an unsuccessful FDA certification audit due to unaddressed “product issues.” The adequate corrective actions needed to check the product issues required analyzing over 50 product failure modes. Each failure mode required a skilled team to analyze its related documentation. The Client needed third-party assistance from a team who could handle processing and analyzing the paperwork and documentation to satisfy the consent decree requirements. 

Approach: Thorough Audits to Resolve Quality System 

We performed verification audits of the Client’s quality systems, as well as in-depth reviews of their DHFs, CAPAs, risk management documentation and all related documents based on consent decree requirements. We put additional focus on the 50 product failures that were unaddressed by the previous third-party group. QualityHub assigned a skilled team to comb through the documents, including reviewers, managers, project managers and FDA experts. This team traveled to the Client’s locations, as remote analysis would not be sufficient to resolve the issues of the Client’s scale. 

Our QualityHub experts worked alongside company management and in-house attorneys to create an effective strategy that satisfied the needs of the consent decree. We also attended additional meetings with the FDA District Office and worked with the Client’s FDA attorneys to devise a solution that would be appropriate and lasting. 

Results: Remaining Vigilant is Key to Quality Products

The Client’s consent decree issues took approximately 18 months from the start of QualityHub’s involvement to finding resolutions that would satisfy the consent decree. Our team conveyed all findings and proposed solutions to the Client’s executive team in a clear and concise manner. This involvement reinforced the fact that the executive team needed to take ownership of any and all FDA decrees. 

Had the Client taken more proactive measures from the initial receipt of the consent decree, compounded issues could have been avoided. Having the appropriate systems in place — particularly those meant to prevent rather than correct — can save companies like this Client millions of dollars in time, resources, additional manpower, and legal fees.