# FDA 483 - Bio-Signal Group Corp. - August 30, 2022

Source: https://www.keypedia.com/records/483/bio-signal-group-corp/2522646e-42ac-4fba-8526-fe4a58846461

> FDA 483 for Bio-Signal Group Corp. on August 30, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bio-Signal Group Corp.
- Inspection Date: 2022-08-30
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Bio-Signal Group Corp. in Acton, MA, a manufacturer of the microEEG device, was cited with four observations during an FDA inspection from August 25-30, 2022. The inspection revealed significant deficiencies in their quality system, including inadequate procedures for corrective and preventive actions, lack of device history records, insufficient environmental controls, and a failure to demonstrate design control compliance. These issues indicate a need for comprehensive improvements across several critical quality system elements.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/bio-signal-group-corp/1a3d494e-8bb8-430b-8abe-54cefb3486b0

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