483
ANALYTICS FOR LIFE INC.ANALYTICS FOR LIFE INC. – FDA 483, Feb 20, 2026
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.
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