# FDA 483 - NextBeam - March 13, 2025

Source: https://www.keypedia.com/records/483/nextbeam/008fd80a-63e3-481e-b09c-30151b369373

> FDA 483 for NextBeam on March 13, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NextBeam
- Inspection Date: 2025-03-13
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: NextBeam, a contract sterilizer in North Sioux City, SD, received a Form FDA-483 citing two significant observations. The firm failed to adequately establish and follow its own procedures for receiving, reviewing, and evaluating customer complaints. Additionally, NextBeam had not developed or implemented written procedures for Medical Device Reporting (MDR).

## Related Officers

- [Clifford F. Long](https://www.keypedia.com/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.keypedia.com/companies/nextbeam/50a36300-885c-498e-ade5-5db6ef2f010f

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d