# FDA 483 - Widex Hearing Aid - October 20, 2025

Source: https://www.keypedia.com/records/483/widex-hearing-aid/738f03ec-d351-4082-abc4-f2ae6a509872

> FDA 483 for Widex Hearing Aid on October 20, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Widex Hearing Aid
- Inspection Date: 2025-10-20
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of WS Audiology USA Inc. in Hauppauge, NY, identified a significant issue with the firm's complaint handling procedures. The company's documented procedure for receiving, reviewing, and evaluating complaints was found to be inadequate, specifically lacking detailed instructions for investigation and documentation of internal records. This indicates a deficiency in the firm's quality system regarding complaint management.

## Related Officers

- [Andrew J. Garufi](https://www.keypedia.com/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

Company: https://www.keypedia.com/companies/widex-hearing-aid/4ff182aa-1015-4995-964a-08cb729718b0

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961