# FDA 483 - Prizm Medical, Inc. - October 25, 2021

Source: https://www.keypedia.com/records/483/prizm-medical-inc/ff51b4aa-d1d3-4963-a935-b54b844185a5

> FDA 483 for Prizm Medical, Inc. on October 25, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prizm Medical, Inc.
- Inspection Date: 2021-10-25
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Prizm Medical, Inc. in Buford, GA, a medical device manufacturer, was inspected by the FDA from October 18-25, 2021. The inspection revealed significant issues with the documentation of acceptance activities for incoming, in-process, and complaint-related testing. Additionally, the firm failed to adequately implement procedures for controlling nonconforming products, including failed circuit boards and customer complaints.

## Related Officers

- [Miaja Umaedi](https://www.keypedia.com/people/miaja-umaedi/0a41661f-08bb-4523-ab09-b17e230068e0)
- [investigator](https://www.keypedia.com/people/aigbokhai-a-dirisu/a3dcb5ac-9940-4443-99f2-82537d6e177b)

Company: https://www.keypedia.com/companies/prizm-medical-inc/98626c47-539c-4836-9b2c-62b502f92f42

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