# FDA 483 - Arch - MedTorque Inc. - December 15, 2023

Source: https://www.keypedia.com/records/483/arch-medtorque-inc/bd3552f4-5162-4ac8-8efe-a415934a84ed

> FDA 483 for Arch - MedTorque Inc. on December 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arch - MedTorque Inc.
- Inspection Date: 2023-12-15
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Arch - MedTorque Inc. in Kenosha, WI, a medical device manufacturer, received a Form FDA 483 for significant quality system deficiencies. The inspection revealed inadequate documentation of corrective and preventive action (CAPA) activities and results, along with inadequately established CAPA procedures. Additionally, the firm's organizational structure was found to be inconsistent with its quality manual regarding key management roles.

## Related Officers

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

Company: https://www.keypedia.com/companies/arch-medtorque-inc/04a497d6-a324-48c7-93eb-57ed1c38ef79

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d