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

Source: https://www.keypedia.com/records/483/waldemar-link-gmbh-co-kg-mfg-site/d72f84d6-c75e-44a1-9c89-19a946f24413

> FDA 483 for Waldemar Link GmbH & Co. KG (Mfg Site) on May 11, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Waldemar Link GmbH & Co. KG (Mfg Site)
- Inspection Date: 2023-05-11
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/waldemar-link-gmbh-co-kg-mfg-site/276b3518-f8e5-4cd7-9393-883b837c46ce

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd