# FDA 483 - MedLaunch Incorporated - September 26, 2025

Source: https://www.keypedia.com/records/483/medlaunch-incorporated/fae5e475-8ae2-4e6b-b35c-bac857b25249

> FDA 483 for MedLaunch Incorporated on September 26, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MedLaunch Incorporated
- Inspection Date: 2025-09-26
- Product Type: device
- Office Name: Atlanta District Office
- Summary: MedLaunch Incorporated, a contract manufacturer in Swannanoa, NC, received four observations during an FDA inspection. The inspection revealed deficiencies primarily related to process validation documentation, device history records, and the establishment and definition of controls over suppliers and products. These issues indicate a need for improved quality system procedures.

## Related Officers

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

Company: https://www.keypedia.com/companies/medlaunch-incorporated/ea68c904-f2e7-4fa4-ab90-1037945aaa20

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