# FDA 483 - Raumedic Inc - March 13, 2026

Source: https://www.keypedia.com/records/483/raumedic-inc/f7185afc-6a83-4064-b867-becbbbaa944a

> FDA 483 for Raumedic Inc on March 13, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Raumedic Inc
- Inspection Date: 2026-03-13
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Raumedic Inc. in Mills River, NC, was inspected by the FDA, resulting in three observations. The inspection revealed issues with process validation change control, inadequate planning and control of production and service provision, and failure to maintain records for verification of purchased products. These findings indicate deficiencies in the firm's quality system and adherence to established procedures.

## Related Officers

- [Alex J. Wild](https://www.keypedia.com/people/alex-j-wild/bb1b66b3-19b9-480e-af0b-f06f8de0d930)

Company: https://www.keypedia.com/companies/raumedic-inc/46827904-c33b-454d-be9b-1aef01976ff2

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7