# FDA 483 - Norman Noble Inc - March 24, 2023

Source: https://www.keypedia.com/records/483/norman-noble-inc/264489f9-d3fc-40e5-a9ac-9ebbef16e0d0

> FDA 483 for Norman Noble Inc on March 24, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Norman Noble Inc
- Inspection Date: 2023-03-24
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Norman Noble Inc, a medical device manufacturer in Highland Heights, OH, received a Form FDA 483 with four observations during an inspection. The firm was cited for significant deficiencies in process validation, including inadequate revalidation of equipment and cleanrooms, and missing documentation. Further issues were identified in the establishment and execution of corrective and preventive action procedures, supplier control, and the management of nonconforming products.

## Related Documents

- [483 - 2024-12-19](https://www.keypedia.com/records/483/norman-noble-inc/66260570-93d2-40da-95c8-c1c2cb985d67)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/matthew-w-kyle/0f297104-ae6c-4fc4-a240-c84e5e907803)
- [Medical Device Specialist](https://www.keypedia.com/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

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

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