# FDA 483 - Creation Technologies Wisconsin Inc - July 20, 2023

Source: https://www.keypedia.com/records/483/creation-technologies-wisconsin-inc/c3b63502-bcd3-4927-bda0-0847b48f18a7

> FDA 483 for Creation Technologies Wisconsin Inc on July 20, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Creation Technologies Wisconsin Inc
- Inspection Date: 2023-07-20
- Product Type: device
- Office Name: Chicago District Office
- Summary: Creation Technologies Wisconsin Inc, a contract manufacturer in Oak Creek, WI, received a Form FDA 483 with three observations. The inspection revealed deficiencies in documenting equipment maintenance activities, including missing electronic signatures, and a failure to adequately update process control procedures following software revisions. Additionally, the firm was cited for inadequately establishing supplier requirements by miscategorizing a critical software supplier.

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.keypedia.com/companies/creation-technologies-wisconsin-inc/35460ba6-2ede-4c01-ba0a-9cb9da7ff216

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