# FDA 483 - Carolina Biological Supply Co - December 17, 2025

Source: https://www.keypedia.com/records/483/carolina-biological-supply-co/0cb0d039-067f-453c-a0fa-ee24d8c22684

> FDA 483 for Carolina Biological Supply Co on December 17, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Carolina Biological Supply Co
- Inspection Date: 2025-12-17
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Carolina Biological Supply Co in Burlington, NC, a manufacturer, revealed a significant quality system deficiency. The firm's internal audit procedure was not followed, as the Quality Management Representative was auditing processes for which they had direct responsibility, indicating a lack of independence in quality oversight. Additionally, the internal audit process itself had not been audited, highlighting a systemic issue in their quality management system.

## Related Documents

- [483 - 2018-03-08](https://www.keypedia.com/records/483/carolina-biological-supply-co/12a4852b-fa38-44c3-81ed-fefc872dd880)
- [483 - 2022-09-23](https://www.keypedia.com/records/483/carolina-biological-supply-co/2784b9f2-6a7b-4794-8b1b-6c70407b1644)

## Related Officers

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

Company: https://www.keypedia.com/companies/carolina-biological-supply-co/d8274b52-7e8c-4347-9650-2f9fa2ecdf14

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