FDA 483 - Aurolab Trust - February 06, 2020

An FDA inspection of Aurolab in Madurai, India, from February 3-6, 2020, identified a significant deficiency in the firm's complaint handling procedures. Specifically, the company failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, including proper documentation and justification for events deemed non-reportable under Medical Device Reporting (MDR) regulations. This indicates a moderate severity issue related to quality system compliance and patient safety reporting.