483
NextBeamFDA 483 - NextBeam - March 13, 2025
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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).
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