FDA 483 - Orthalign, Inc - May 02, 2017

During an FDA inspection conducted from April 24 to May 2, 2017, medical device manufacturer Orthalign, Inc. received a Form FDA 483 citing five significant observations regarding its quality system. The regulatory framework for these issues stems from the FDA's Quality System Regulation for medical devices.

The main violations involved deficiencies across several critical areas. Orthalign failed to adequately establish and implement procedures for design transfer, resulting in production of a device (Hip Align Direct Anterior Leg Length and Offset) before its design transfer was approved. Design verification was also found lacking, as a device specification for leg offset exceeded defined acceptance criteria without proper justification. Furthermore, the company lacked adequate procedures for design validation, specifically concerning the management and tracking of software anomalies, with several issues remaining unaddressed for extended periods.

Deficiencies extended to corrective and preventive actions (CAPA), where the firm's procedures did not clearly define action limits for initiating CAPA based on quality data, and an observed threshold for "Instrument" issues was surpassed without action. Finally, Orthalign failed to adequately control non-conforming products, as evidenced by an open nonconforming material report lacking proper disposition for incorrect printed circuit board assemblies. Orthalign is required to address these observations by implementing comprehensive corrective actions to ensure compliance with quality system regulations.