# Barnett International Corporation – FDA 483, Jul 30, 2026

Source: https://www.keypedia.com/records/483/barnett-international-corporation/4b030fbf-b692-4951-b7a6-b8b1630722d9

> FDA 483 for Barnett International Corporation on July 30, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Barnett International Corporation
- Inspection Date: 2026-07-30
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Barnett International Corporation in Stallings, NC, revealed significant deficiencies in their quality system, specifically regarding record-keeping for Class II medical device packaging. The firm failed to maintain records for process checks and material changes, and lacked written procedures for process validation, design control, or change control. These issues indicate a moderate severity of non-compliance with regulatory requirements for medical device manufacturing.

## Related Officers

- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.keypedia.com/companies/barnett-international-corporation/9192b3c6-85ff-4a77-ad5b-bcc54b552765

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