483
Fortell Research Inc.Fortell Research Inc. – FDA 483, Apr 23, 2026
Record Details
Fortell Research Inc. in Danbury, CT, a medical device manufacturer, was cited for inadequate corrective actions during an FDA inspection. The firm failed to open a CAPA despite multiple in-process failures and a field complaint related to defective hearing aid receiver connector solder joints. This indicates a significant lapse in preventing the recurrence of nonconformities and updating risk management.
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ID · 7f05423f-68ec-420d-a255-64c75c1459e3
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