483
TruCore Distributors IncTruCore Distributors Inc – FDA 483, Mar 10, 2020
Record Details
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.
View Company Profile
ID · fe33e001-b06c-4c85-b600-d6aa406a1a6b
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.