FDA 483 - Elucid Bioimaging Inc. - March 20, 2026
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Elucid Bioimaging Inc., a medical device manufacturer in Boston, MA, was cited for deficiencies in its complaint handling procedures. The inspection revealed that the firm's procedures did not adequately define when complaints require corrective and preventive action, failed to conduct Medical Device Reporting determinations within required timeframes, and lacked provisions for documenting unique device identifiers (UDI) or Universal Product Codes (UPC) in complaint records.
ID · c00b5f66-4d79-4925-8b26-c91765aba278