# Fortell Research Inc. – FDA 483, Apr 23, 2026

Source: https://www.keypedia.com/records/483/fortell-research-inc/7f05423f-68ec-420d-a255-64c75c1459e3

> FDA 483 for Fortell Research Inc. on April 23, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fortell Research Inc.
- Inspection Date: 2026-04-23
- Product Type: device
- Office Name: New England District Office
- Summary: 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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Company: https://www.keypedia.com/companies/fortell-research-inc/a1767de7-a575-4d23-a5de-1fd5333ba003

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144
