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

Source: https://www.keypedia.com/records/483/design-and-services-hub/9ff57fb2-be50-47e5-a14c-f33bd7f95b49

> FDA 483 for Design and Services Hub on September 08, 2025. Product: devices. 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: devices
- Summary: During an FDA inspection conducted from September 3-8, 2025, Design and Services Hub, a contract medical device manufacturer in Hartville, OH, received a Form FDA 483 detailing significant quality system deficiencies. The observations highlight the need for improved adherence to the regulatory framework governing medical device manufacturing.The primary issues identified involve three key areas. Firstly, the company's procedures for managing nonconforming products were found inadequate. Specifically, not all identified nonconformances, particularly those dispositioned as "scrap," were formally documented, and risk assessment for these issues lacked detailed guidance. Furthermore, nonconformance data was not consistently used for quality analysis, supplier evaluation, or updating process FMEAs.Secondly, the firm's complaint management system was insufficient. Procedures did not ensure proper documentation of reported complaints, and there was a lack of clear guidelines for defining a "complaint" as a contract manufacturer, required investigative information, and communication protocols with original equipment manufacturers (OEMs).Finally, Design and Services Hub's procedures for evaluating and monitoring suppliers were not adequately established. The method for using quality data to approve and monitor suppliers was unclear, particularly regarding acceptable levels of nonconforming products and necessary follow-up actions. Crucially, nonconformance data was not being utilized to monitor supplier quality effectively.Design and Services Hub has committed to correcting all observations by December 31, 2025, to address these quality system violations.

## Related Documents

- [483 - 2025-09-08](https://www.keypedia.com/records/483/design-and-services-hub/aa2648a1-2c34-44aa-8507-4f1afd43b543)

## 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