Two Informative FDA Compliance Remediation Case Studies

At QualityHub, we have experience in FDA compliance remediation for several types of companies and situations. Here are two examples of FDA compliance remediation case studies to give you some background on that experience.

1. Full Quality System Rebuild & FDA Remediation

FDA Compliance Remediation Case Study

For a medical device implant manufacturer, we provided a full quality system rebuild and remediation. The front-end of this project included baseline audits of their manufacturing sites in the U.S. and Europe. Based on gaps identified by the FDA and the QualityHub audits, we created a compliance master plan (CMP) that guided the project. The CMP included interim controls, future state (a rebuilt quality system) and remediation activities.

In parallel to the CMP work, we created FDA 483 proof books and coached the company on handling the next FDA inspection. QualityHub brought in a project leader, project managers, executive coach, ex-FDA mock investigators, team subject matter experts (SMEs), and numerous associate-level consultants to assist with the day-to-day work at the company as well as the remediation work. The company passed their next FDA inspection. The project lasted fourteen months.

2. Second Warning Letter Remediation

FDA Compliance Remediation Case Study

For a medical device manufacturer with many sites worldwide, QualityHub was hired after they received a second warning letter. We helped with the creation of a compliance master plan (CMP). We provided subject matter experts (SMEs) to work with company workstream owners and guided the creation of new processes, procedures, and the remediation of various quality system records such as complaints, MDRs, CAPAs and device history records. We also provided audits at sites worldwide. Finally, we helped sites worldwide prepare for their FDA inspections.

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