# FDA 483 - FHC, Inc. - July 24, 2019

Source: https://www.keypedia.com/records/483/fhc-inc/e6cae3f6-dca8-499b-bd7f-add417bf9bd4

> FDA 483 for FHC, Inc. on July 24, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FHC, Inc.
- Inspection Date: 2019-07-24
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: PHC, Inc. in Bowdoin, ME, a medical device manufacturer, was inspected and cited for three observations related to its quality system. The inspection revealed deficiencies in documenting design review results, translating device design into production specifications, and establishing adequate corrective and preventive action procedures. These issues indicate a lack of robust control over design and manufacturing processes for their microTargeting Microtable device.

## Related Documents

- [483 - 2025-07-10](https://www.keypedia.com/records/483/fhc-inc/42dfb5b0-2905-4918-a4a4-058450c0d429)

## Related Officers

- [Business Owner](https://www.keypedia.com/people/james-whitney/072bf37e-a5c6-41bb-b0c1-1f944b112b43)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94