# FDA 483 - Norman Noble Inc - December 19, 2024

Source: https://www.globalkeysolutions.net/records/483/norman-noble-inc/66260570-93d2-40da-95c8-c1c2cb985d67

> FDA 483 for Norman Noble Inc on December 19, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Norman Noble Inc
- Inspection Date: 2024-12-19
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Norman Noble Inc, a medical device manufacturer in Highland Heights, OH, received two observations during an FDA inspection. The firm was cited for inadequate process validation, specifically concerning software used in final inspection, which was a repeat observation. Additionally, deficiencies were noted in their clean room environmental control procedures, with particulate testing failing to meet ISO Class 7 standards.

## Related Documents

- [483 - 2023-03-24](https://www.globalkeysolutions.net/records/483/norman-noble-inc/264489f9-d3fc-40e5-a9ac-9ebbef16e0d0)

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

Company: https://www.globalkeysolutions.net/companies/norman-noble-inc/714904c9-daa8-4596-8ac6-6c6edb87abae

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