# FDA 483 - Konica Minolta, Inc. - April 05, 2023

Source: https://www.globalkeysolutions.net/records/483/konica-minolta-inc/412f0dc6-361c-4ce8-ae90-a2b092e4f567

> FDA 483 for Konica Minolta, Inc. on April 05, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Konica Minolta, Inc.
- Inspection Date: 2023-04-05
- Product Type: device
- Office Name: Office of Biological Products Operations - Division I
- Summary: Konica Minolta, Inc. in Hachioji, Tokyo, Japan, a specification developer, was cited for significant deficiencies in its medical device design control processes. The inspection revealed inadequate procedures for design review, insufficient documentation of design verification results in the design history file, and a lack of documentation for design validation results. These issues indicate a systemic breakdown in ensuring device safety and effectiveness through proper design controls.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/catherine-j-laufmann/920b7656-2847-408d-ba15-3989283d8c94)

Company: https://www.globalkeysolutions.net/companies/konica-minolta-inc/b76ca4db-ca56-41e7-bdf6-1841b545d2e9

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1