# FDA 483 - Circuit Works Corporation - February 15, 2022

Source: https://www.keypedia.com/records/483/circuit-works-corporation/eeafb120-15fb-4f06-b6b6-13cd58ba392c

> FDA 483 for Circuit Works Corporation on February 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Circuit Works Corporation
- Inspection Date: 2022-02-15
- Product Type: device
- Office Name: Chicago District Office
- Summary: Circuit Works Corporation, a medical device contract manufacturer in Waukegan, IL, was inspected and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in their quality system, including repeat observations from a 2017 inspection concerning corrective and preventive actions, process validation, and internal audit independence. The firm also lacked established procedures for in-process product acceptance.

## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

Company: https://www.keypedia.com/companies/circuit-works-corporation/937dddf2-51ba-4128-b9d8-387a6b58ff40

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669