# FDA 483 - Microvapor Devices LLC - July 18, 2025

Source: https://www.globalkeysolutions.net/records/483/microvapor-devices-llc/d1684035-fe3a-4ff0-a4e8-22dd340b3968

> FDA 483 for Microvapor Devices LLC on July 18, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Microvapor Devices LLC
- Inspection Date: 2025-07-18
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Microvapor Devices LLC in West Columbia, SC, revealed seven significant observations regarding their manufacturing processes for Class II medical devices, including the Pocket Nebulizer. Deficiencies were noted in design validation, labeling control, device master records, equipment calibration, complaint handling, device history records, and incoming product acceptance. These issues collectively indicate a lack of adherence to established quality system regulations.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/microvapor-devices-llc/37933821-7ac5-41a5-8f21-cfa511fbdacd

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