FDA 483 - TruCore Distributors Inc - March 10, 2020

TruCore Distributors Inc, a medical device relabeler in Kings Park, NY, was cited for a significant deficiency related to its quality system. The inspection revealed a lack of written procedures for electronic Medical Device Reporting (eMDR), specifically for handling incidents involving serious injuries and death. This indicates a critical gap in the firm's ability to report adverse events as required.