FDA 483 - CurvaFix, Inc. - April 24, 2025

CurvaFix, Inc. in Bellevue, WA, a manufacturer of the Class II CurvaFix IM System, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning the documentation and processing of corrective and preventive actions, the establishment and adherence to complaint handling procedures, and the re-evaluation of suppliers. These issues indicate a lack of control over critical quality processes.