# FDA 483 - Carolon Company - June 15, 2023

Source: https://www.keypedia.com/records/483/carolon-company/10cdefb1-2149-41ae-a636-b81b1ef6bc93

> FDA 483 for Carolon Company on June 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Carolon Company
- Inspection Date: 2023-06-15
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Carolon Company in Rural Hall, NC, revealed significant deficiencies across its quality management system for medical device manufacturing. The firm failed to adequately establish and follow procedures for complaint handling, medical device reporting, corrective and preventive actions, non-conforming product control, device history records, and internal quality audits. These findings indicate a systemic breakdown in maintaining compliance with regulatory requirements.

## Related Officers

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

Company: https://www.keypedia.com/companies/carolon-company/0cf14122-8946-4fcc-8af2-b3d7664131f3

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