RetroPerc, Inc. – FDA 483, Dec 18, 2024

During an FDA inspection from December 11 to 18, 2024, RetroPerc, Inc., a medical device specification developer in Jersey City, NJ, received a Form 483 detailing significant quality system deficiencies. The main violations, governed by medical device Quality System Regulations, centered on several areas. Firstly, design control procedures for the RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set were not adequately established or followed. This included failures to properly assess design changes (e.g., biocompatibility and performance testing for material, process, and supplier changes), complete design reviews for various phases, and approve the Design Input Verification Matrix. Secondly, the firm did not sufficiently ensure that purchased products and services conformed to specified requirements. This involved inadequate evaluation and monitoring of their contract manufacturer and unapproved suppliers for critical device components. Additional issues included a lack of regular management reviews and internal quality audits, which were significantly overdue per the company's own procedures. Furthermore, RetroPerc, Inc. failed to submit required Unique Device Identification (UDI) information to the Global UDI Database for its commercially distributed device. Lastly, consultant training was not adequately documented or implemented according to the firm's training procedure. RetroPerc, Inc. is required to implement robust corrective actions to address these systemic compliance failures.