FDA 483 - Waldemar Link GmbH & Co. KG (Mfg Site) - May 11, 2023

The FDA issued a Form 483 to Waldemar Link GmbH & Co. KG (Mfg Site) following an inspection conducted from May 8-11, 2023, in Norderstedt, Germany. The inspection revealed several significant violations related to the firm's quality system for medical devices. A primary concern, identified as a repeat observation, was the inadequate establishment of corrective and preventive action (CAPA) procedures. The company failed to initiate CAPAs for at least twenty complaints regarding the LinkSymphoKnee plateau not fully engaging, a recall of Endo-Model M femoral segments due to improper seating, and an incorrectly assembled screw in a LinkSymphoKnee augment. Furthermore, the effectiveness verification for existing CAPAs was found to be insufficient. Additional observations included sampling plans that lacked valid statistical rationale and inadequate risk analysis for the LinkSymphoKnee device, which did not align with complaint trends. The FDA also noted critical failures in regulatory reporting, specifically the omission of a report to FDA for a recall involving Endo Model M Femoral Segments and the failure to submit Medical Device Reports (MDRs) within the required 30 days for 18 complaints concerning LinkSymphoKnee plateau engagement issues, despite similar events previously warranting MDRs. In response to these observations, Waldemar Link GmbH & Co. KG committed to correcting all identified issues.