WALDEMAR LINK GMBH & CO. KGAugust 22, 2019

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

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore WALDEMAR LINK GMBH & CO. KG

Record Details

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.

Company: WALDEMAR LINK GMBH & CO. KG
Inspection Date: August 22, 2019
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: James R. Montero

Open in Dashboard

ID · 1b4225be-aed4-41c4-b444-e1984c16b283