FDA 483 - Renton Surgical, LLC - March 23, 2018

An FDA inspection of Renton Surgical, LLC, a medical device specification developer in Georgetown, IN, was conducted from March 22-23, 2018. The inspection, led by Investigator Shannon A Gregory, identified two significant observations documented on Form FDA 483, highlighting critical deficiencies in the firm's quality system procedures. The primary issues included the absence of adequately established written procedures for corrective and preventive actions (CAPA). This is essential for systematically identifying, investigating, and resolving product or process nonconformities to prevent their recurrence. Additionally, the company had not developed written procedures for Medical Device Reporting (MDR), which are crucial for promptly reporting adverse events and product malfunctions to the FDA, ensuring patient safety and regulatory oversight. Both observations fall under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. Renton Surgical, LLC, through its President/CEO, Derric Renton, acknowledged these deficiencies during the inspection and committed to implementing corrective actions. The firm is now required to develop and formally implement these missing written procedures to achieve compliance with quality system requirements and effectively address the identified observations.