483
KeriCure Inc.FDA 483 - KeriCure Inc. - June 11, 2026
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An FDA inspection of Kericure Inc., a medical device manufacturer in Maitland, FL, revealed significant deficiencies in their quality management system. Observations included inadequate risk management records, unapproved process validation reports, and outdated quality system documentation that failed to comply with current regulatory requirements. Additionally, the firm's complaint handling procedures were found to be insufficient.
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