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

Source: https://www.keypedia.com/records/483/waldemar-link-gmbh-co-kg/1b4225be-aed4-41c4-b444-e1984c16b283

> FDA 483 for WALDEMAR LINK GMBH & CO. KG on August 22, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WALDEMAR LINK GMBH & CO. KG
- Inspection Date: 2019-08-22
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [James R. Montero](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.keypedia.com/companies/waldemar-link-gmbh-co-kg/425c9e5b-f518-4723-9888-d50805c00be1

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