# FDA 483 - Health Beacons, Inc. - August 03, 2022

Source: https://www.keypedia.com/records/483/health-beacons-inc/3b297fe5-be7a-4c6c-8f88-d42441dded59

> FDA 483 for Health Beacons, Inc. on August 03, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Health Beacons, Inc.
- Inspection Date: 2022-08-03
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Health Beacons, Inc. in Marlborough, MA, revealed inadequate procedures for corrective and preventive actions. The firm experienced multiple instances of late Medical Device Report (MDR) submissions due to incorrect complaint assessments. These deficiencies led to patient harm, including prolonged procedures and rescheduled surgeries.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)
- [Kayla R. Huffman](https://www.keypedia.com/people/kayla-r-huffman/86044a8a-5f35-43de-a293-05563c7cf891)

Company: https://www.keypedia.com/companies/health-beacons-inc/93890cd6-2a94-48b1-9b97-bcf222c912b0

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