# FDA 483 - Precision Diabetes Inc. - March 08, 2024

Source: https://www.keypedia.com/records/483/precision-diabetes-inc/d7cddca2-c595-419c-9449-6b70c3fbe1e4

> FDA 483 for Precision Diabetes Inc. on March 08, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Precision Diabetes Inc.
- Inspection Date: 2024-03-08
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Precision Diabetes Inc., a specification developer of Class II GlycoMark® IVD kits in Raleigh, NC, was inspected by the FDA. The inspection revealed significant deficiencies across multiple quality system areas, indicating a broad breakdown in the firm's quality management system. Observations included a lack of established procedures for design control, corrective and preventive action, nonconforming product, supplier management, acceptance activities, and management review, alongside a failure to perform internal quality audits.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/inga-m-warr/f27805b8-c2ba-4af5-bf5e-ff2e2f511ec1)

Company: https://www.keypedia.com/companies/precision-diabetes-inc/412e92c1-7db7-46b1-a44c-99300d81fea2

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