ANALYTICS FOR LIFE INC.February 20, 2026

FDA 483 - ANALYTICS FOR LIFE INC. - February 20, 2026

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Record Details

An FDA inspection of ANALYTICS FOR LIFE INC., a medical device manufacturer in Bethesda, MD, revealed significant deficiencies in its quality management system. The firm failed to maintain proper complaint handling records for its CorVista System, specifically regarding Signal Quality Assessment failures. Additionally, procedures for the feedback process were found to be inadequately documented, lacking provisions for data gathering from production and post-production activities.

Company: ANALYTICS FOR LIFE INC.
Inspection Date: February 20, 2026
Product Type: Device
Office: Baltimore District Office
Person: Jude C. Dike

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ID · e3924743-eb0b-4999-aab8-e64677187f71