# FDA 483 - Healthplus LLC - August 07, 2025

Source: https://www.globalkeysolutions.net/records/483/healthplus-llc/31d7bbec-94c0-4ecb-a9e6-c6a1d1ca7aa5

> FDA 483 for Healthplus LLC on August 07, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Healthplus LLC
- Inspection Date: 2025-08-07
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Healthplus LLC in Asheville, NC, from August 4-7, 2025, identified one significant observation. The firm failed to adequately validate the design of a Class II medical device using initial production units, lacking sufficient records to confirm the manufacturing and acceptance of devices used in validation activities. This indicates a deficiency in their design control processes.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/healthplus-llc/2a9eb8a3-d569-4bcb-ab44-fb97abaeb62f

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