FDA 483 - WALDEMAR LINK GMBH & CO. KG - August 22, 2019

An FDA inspection of WALDEMAR LINK GMBH & CO. KG, a medical device manufacturer in Norderstedt, Germany, revealed two significant observations. The firm was cited for inadequate process validation, specifically concerning the pouch sealing of an ankle prosthetic device, where observed sealing temperatures deviated from validated parameters. Additionally, the inspection found deficiencies in the documentation and timely closure of corrective and preventive actions.