FDA 483 - CurvaFix, Inc. - August 23, 2023

An FDA inspection of CurvaFix, Inc. in Bellevue, WA, a manufacturer of Class 2 medical devices, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for medical device reporting, quality audits, corrective and preventive actions, and supplier management. Additionally, issues were noted with the justification for not reporting correction/removal actions and the statistical rationale for sampling plans.