483
Keranetics Inc.Keranetics Inc. – FDA 483, Feb 6, 2025
Record Details
Keranetics Inc. in Winston Salem, NC, a specification developer, was inspected by the FDA from February 5-6, 2025. The inspection revealed significant deficiencies in the firm's quality system, including a lack of written Medical Device Reporting (MDR) procedures, inadequate complaint handling, failure to conduct management reviews, and absence of quality audits. These findings indicate a broad failure to maintain essential quality system controls.
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- Atlanta District Office
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ID · 49e209af-8b2c-4b46-9eac-a08246b26055
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