# FDA 483 - Cathtek LLC - February 27, 2025

Source: https://www.keypedia.com/records/483/cathtek-llc/fadcda3e-9bbf-4e81-a02b-3dfe97f8a630

> FDA 483 for Cathtek LLC on February 27, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cathtek LLC
- Inspection Date: 2025-02-27
- Product Type: other
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Cathtek LLC, a contract manufacturer in Walkertown, NC, revealed significant deficiencies in their quality system. The firm failed to adequately document corrective and preventive action activities, specifically an open CAPA for over 24 months without resolution. Additionally, the inspection found a lack of documentation for equipment maintenance activities, including preventive and corrective maintenance records for assembly machines and other components.

## Related Officers

- [Lashawn M. Elam](https://www.keypedia.com/people/lashawn-m-elam/23bee423-c2f7-4977-bc32-2d4c40fc521f)
- [Christopher B. May](https://www.keypedia.com/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)

Company: https://www.keypedia.com/companies/cathtek-llc/1c16aaa6-6fb2-4ba0-a572-818f240c0a1b

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7