# FDA 483 - Carroll-Baccari Inc - August 05, 2025

Source: https://www.globalkeysolutions.net/records/483/carroll-baccari-inc/6b0aadaa-a56b-4046-91be-9e0a49adf937

> FDA 483 for Carroll-Baccari Inc on August 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Carroll-Baccari Inc
- Inspection Date: 2025-08-05
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: The FDA inspection of Mavidon Medical Products in Flat Rock, NC, revealed widespread deficiencies across its quality management system, indicating a lack of adequate controls for medical device manufacturing. Significant issues include ineffective corrective and preventive actions, inadequate control of non-conforming products, and insufficient process controls. The firm also failed to establish proper procedures for complaint handling, equipment calibration, supplier management, product identification, software validation, MDR reporting, personnel training, and document control, posing risks to product quality and patient safety.

## Related Officers

- [Benjamin E. Bowen](https://www.globalkeysolutions.net/people/benjamin-e-bowen/7fdc5755-0d5d-45c9-93a0-3cb928156c1d)

Company: https://www.globalkeysolutions.net/companies/carroll-baccari-inc/0f140770-4266-4e54-9553-1a2e5b587ffd

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