# Norwood Medical, LLC – FDA 483, Apr 17, 2026

Source: https://www.keypedia.com/records/483/norwood-medical-llc/d17b97f7-b56e-4a10-a344-70ea27dd58fc

> FDA 483 for Norwood Medical, LLC on April 17, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Norwood Medical, LLC
- Inspection Date: 2026-04-17
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Norwood Medical, LLC, a medical device manufacturer in Dayton, OH, was inspected by the FDA and received a Form 483. The inspection revealed significant issues with the firm's supplier management, including inadequate planning for monitoring and re-evaluation, and failures in qualifying suppliers and documenting changes. Additionally, the firm's risk management activities related to product realization were found to be inadequately maintained, with deficiencies in updating Process Failure Mode and Effects Analysis (pFMEA) and defining severity rankings.

## Related Officers

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

Company: https://www.keypedia.com/companies/norwood-medical-llc/32b8461d-d38c-425f-9525-832a94272afc

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