# FDA 483 - Reflexonic, LLC - September 24, 2025

Source: https://www.keypedia.com/records/483/reflexonic-llc/b2a16ec3-ea7b-438e-bcac-0ee32e37fc02

> FDA 483 for Reflexonic, LLC on September 24, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reflexonic, LLC
- Inspection Date: 2025-09-24
- Product Type: device
- Office Name: Baltimore District Office
- Summary: An FDA inspection of Reflexonic, LLC in Leesburg, VA, a medical device specification developer, revealed significant deficiencies across its quality management system. The firm failed to establish adequate design controls, purchasing controls, complaint handling, and corrective and preventive action procedures. Additionally, the inspection found issues with device master records, organizational structure, quality audits, management reviews, and the implementation of Unique Device Identifier (UDI) requirements for its products.

## Related Documents

- [483 - 2016-04-19](https://www.keypedia.com/records/483/reflexonic-llc/cee9a606-a6d4-4657-bb07-5167e1de1b78)

## Related Officers

- [Heath A. Gerber](https://www.keypedia.com/people/heath-a-gerber/3c47dcdd-875c-4f3c-8165-839354a53d8b)
- [Katelyn A. Staub-Zamperini](https://www.keypedia.com/people/katelyn-a-staub-zamperini/bb7f95a4-53c1-473c-856e-517312bdba30)

Company: https://www.keypedia.com/companies/reflexonic-llc/5573866a-b9b9-4844-8a5a-54641b8125d4

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa