# FDA 483 - BSN Medical Inc - March 22, 2021

Source: https://www.globalkeysolutions.net/records/483/bsn-medical-inc/ba1460cd-5a0b-49ea-b5fe-6f997aa310d8

> FDA 483 for BSN Medical Inc on March 22, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BSN Medical Inc
- Inspection Date: 2021-03-22
- Product Type: device
- Office Name: Atlanta District Office
- Summary: BSN Medical Inc. in Charlotte, NC, a specification developer and complaint unit, was inspected from March 15-22, 2021. The inspection revealed significant deficiencies in design control, process validation, and documentation practices. These issues indicate a lack of robust quality system implementation, particularly concerning design validation, process records, and timely approval of design inputs and outputs.

## Related Documents

- [483 - 2025-09-05](https://www.globalkeysolutions.net/records/483/bsn-medical-inc/be9146c0-9f37-49a5-83c6-c0003a67c1a4)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/bsn-medical-inc/01f25415-fe2a-4784-be4d-0088803e6f78

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