# FDA 483 - Design and Services Hub - September 08, 2025

Source: https://www.keypedia.com/records/483/design-and-services-hub/aa2648a1-2c34-44aa-8507-4f1afd43b543

> FDA 483 for Design and Services Hub on September 08, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Design and Services Hub
- Inspection Date: 2025-09-08
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Design and Services Hub, a contract medical device manufacturer in Hartville, OH, revealed significant deficiencies in their quality system. Observations included inadequate procedures for managing nonconforming products, a lack of established complaint handling processes, and insufficient supplier evaluation procedures. These issues indicate a need for comprehensive improvements in their quality management system.

## Related Documents

- [483 - 2025-09-08](https://www.keypedia.com/records/483/design-and-services-hub/9ff57fb2-be50-47e5-a14c-f33bd7f95b49)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

Company: https://www.keypedia.com/companies/design-and-services-hub/a7158e6b-a760-4f95-b417-09e7195e5aa3

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22