Cordis US Corp – FDA EIR, Jan 30, 2014

An FDA inspection of Cordis Corporation's Miami Lakes facility occurred from January 16 to January 30, 2014. The inspection, conducted under Compliance Program 7383.001, evaluated the company's adherence to Medical Device Reporting (MDR) regulations, Quality System (QS) regulation requirements, and Premarket Approval (PMA) commitments for Class II and III cardiovascular devices. While no formal FDA Form 483 was issued, the inspection highlighted several verbal observations for management attention.

Key issues included the Miami facility's insufficient oversight of complaint investigations performed by its Juarez, Mexico counterpart, specifically in ensuring complete documentation and procedural adherence before closing complaint files. Concerns were also raised regarding the thoroughness of troubleshooting matrices used for root cause determination, suggesting they might not encompass all potential causes. Furthermore, the inspection noted inadequate documentation practices for quality records, citing uninitialed or undated notes on recall acknowledgment forms and unverified electronic additions to official documents.

Cordis Corporation management acknowledged these observations, stating their intention to comply. Implied required actions involve enhancing oversight of outsourced complaint investigations, strengthening root cause analysis processes, and implementing improved, controlled documentation practices for all quality-related activities, including recall follow-ups, to ensure accurate and verifiable records.