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

Waldemar Link GmbH & Co. KG in Norderstedt, Germany, was cited with five observations during an FDA inspection from May 8-11, 2023. The inspection revealed significant deficiencies in the firm's quality system, including inadequate corrective and preventive actions, statistically invalid sampling plans, and insufficient risk analysis. Furthermore, the firm failed to report a device recall to the FDA and did not submit required Medical Device Reports for multiple LinkSymphoKnee malfunctions.