FDA 483 - Careox, Llc - August 29, 2025

An FDA inspection, conducted by Investigator Frank J. Marciniak from August 27 to August 29, 2025, at an unspecified firm, resulted in two significant observations documented in an FDA Form 483. The inspection aimed to assess compliance with regulatory requirements, particularly under Section 704(b) of the Federal Food, Drug and Cosmetic Act. The primary violations centered on critical deficiencies in the firm's quality management system. Firstly, the inspection revealed a complete absence of written procedures for Medical Device Reporting (MDR), which are essential for tracking and reporting adverse events related to medical devices. Secondly, the firm lacked established written procedures for managing customer complaints, including their reception, review, and evaluation by a formally designated unit. These omissions indicate a fundamental gap in the company's operational controls and regulatory adherence. In response to these findings, the firm, whose President and CEO is identified as Young Kim, committed to addressing the observations. The company promised to correct the MDR procedure deficiency by September 5, 2025, and to establish the necessary complaint handling procedures by May 29, 2025, as noted in the inspection annotations. These actions are crucial for the firm to resolve the identified non-compliances and ensure future regulatory compliance.