FDA 483 - Theken Companies LLC - July 02, 2010

Theken Spine LLC, a medical device manufacturer, was inspected by the FDA from June 14 to July 2, 2010, revealing significant compliance deficiencies. The regulatory framework for medical device quality systems requires strict adherence to procedures for product safety and accountability. A primary observation was the company's failure to submit numerous Medical Device Reports (MDRs) within the mandated 30-day timeframe for device malfunctions. Specifically, over 30% of reviewed complaint files involved reportable events, such as locking screws separating, devices breaking during surgery, and instruments failing, which were not reported to the FDA, and several other MDRs were submitted late. Furthermore, the inspection identified inadequate process validation. The cleaning process for reusable spinal implant tools lacked full validation for critical parameters like time, temperature, and detergent concentration. There was also insufficient evidence that device materials could withstand repeated sterilization cycles without degradation, despite high estimated cumulative sterilization times. Finally, the firm's Corrective and Preventive Action (CAPA) system was found deficient. CAPA files for serious device malfunctions, including those deemed "High Risk" and requiring field action, lacked adequate justification for not initiating field recalls. Additionally, corrective actions for non-conforming materials were managed informally via email, bypassing established CAPA procedures. The company committed to correcting all observations.