483
Conformis Inc.Conformis Inc. – FDA 483, Jan 13, 2026
Record Details
An FDA inspection of Conformis Inc. in Wilmington, MA, revealed inadequate procedures for receiving, reviewing, and evaluating complaints. Specifically, a significant number of complaint files lacked the required Unique Device Identifier (UDI) or Universal Product Code (UPC) documentation. This indicates a notable deficiency in the firm's complaint handling system for its medical devices.
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ID · 4a31c65b-4c78-4f08-b960-e46f144b7acc
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