# FDA 483 - Biomerics Winston-Salem - May 21, 2026

Source: https://www.keypedia.com/records/483/biomerics-winston-salem/2edb7a5c-e04f-40d9-8853-a5bb3c6ce1c6

> FDA 483 for Biomerics Winston-Salem on May 21, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomerics Winston-Salem
- Inspection Date: 2026-05-21
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Biomerics Precision Concepts Group in Winston Salem, NC, revealed two significant observations. The firm failed to adequately document risk management processes for product realization, specifically regarding controlled storage requirements and temperature data logging. Additionally, procedures for timely complaint handling were found to be inadequately documented, with several complaint records lacking required information.

## Related Officers

- [Christopher B. May](https://www.keypedia.com/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)

Company: https://www.keypedia.com/companies/biomerics-winston-salem/b318f929-e409-4b52-9834-73d6def463b4

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7