# FDA 483 - Daniels Manufacturing Operations Inc - November 08, 2023

Source: https://www.keypedia.com/records/483/daniels-manufacturing-operations-inc/dfad89fc-b987-4359-b58e-7f6fa10e1060

> FDA 483 for Daniels Manufacturing Operations Inc on November 08, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Daniels Manufacturing Operations Inc
- Inspection Date: 2023-11-08
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Daniels Manufacturing Operations Inc, a contract manufacturer in Racine, WI, was cited for multiple deficiencies in its quality management system. The inspection revealed inadequate documentation of corrective and preventive actions, insufficient procedures for equipment calibration and maintenance, and a complete lack of quality audit procedures. Furthermore, management failed to conduct required reviews of the quality system and ensure the quality policy was understood by employees.

## Related Officers

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

Company: https://www.keypedia.com/companies/daniels-manufacturing-operations-inc/ddaa12df-85b6-407f-8c28-083cb1269bcc

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