# FDA 483 - Omni-Guide Holdings, Inc. - August 19, 2022

Source: https://www.keypedia.com/records/483/omni-guide-holdings-inc/88a305d0-2e2c-431e-a6f9-ee545d797e09

> FDA 483 for Omni-Guide Holdings, Inc. on August 19, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Omni-Guide Holdings, Inc.
- Inspection Date: 2022-08-19
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Omni-Guide Holdings, Inc. in Billerica, MA, a medical device manufacturer, was inspected by the FDA. The inspection revealed one significant observation related to regulatory compliance. The firm failed to submit a required product report for its Beacon Advanced Energy Laser System, despite the device having received 510k approval and being distributed in commerce.

## Related Officers

- [Emir Galevi](https://www.keypedia.com/people/emir-galevi/d99d0e13-df64-44a8-af6e-ef28ff50b5b9)
- [Preston M. Lee](https://www.keypedia.com/people/preston-m-lee/e44adac3-a915-4bfb-8b06-a41ea5803358)

Company: https://www.keypedia.com/companies/omni-guide-holdings-inc/5e155363-4080-4984-aa63-81ad46877ef5

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