# FDA 483 - FHC, Inc. - July 10, 2025

Source: https://www.keypedia.com/records/483/fhc-inc/42dfb5b0-2905-4918-a4a4-058450c0d429

> FDA 483 for FHC, Inc. on July 10, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FHC, Inc.
- Inspection Date: 2025-07-10
- Product Type: device
- Office Name: New England District Office
- Summary: FHC, Inc., a medical device manufacturer in Bowdoin, ME, was cited with two observations during an FDA inspection. The firm failed to adequately establish and implement complaint handling procedures, resulting in incomplete investigations for specific medical device platforms. Additionally, the company did not timely communicate changes to design validation and risk assessment documents, leading to the use of outdated information.

## Related Documents

- [483 - 2019-07-24](https://www.keypedia.com/records/483/fhc-inc/e6cae3f6-dca8-499b-bd7f-add417bf9bd4)

## Related Officers

- [investigator](https://www.keypedia.com/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)

Company: https://www.keypedia.com/companies/fhc-inc/ad3d6d9e-f0ec-4265-83c6-9d06e50ca1da

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