# FDA 483 - etectRX LLC. - August 01, 2025

Source: https://www.keypedia.com/records/483/etectrx-llc/ba7943e7-4a02-4083-a611-7908fc7e831c

> FDA 483 for etectRX LLC. on August 01, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: etectRX LLC.
- Inspection Date: 2025-08-01
- Product Type: device
- Office Name: Florida District Office
- Summary: An FDA inspection of etectRX LLC. in Gainesville, FL, revealed significant deficiencies in their quality system for medical device manufacturing. Observations included failures in production process controls, inadequate supplier qualification, improper complaint handling, and non-compliance with Unique Device Identifier (UDI) requirements for device labeling and database submission. These issues indicate a broad lack of adherence to established procedures and regulatory standards.

## Related Officers

- [Marvin A. Marenco](https://www.keypedia.com/people/marvin-a-marenco/b4638545-ba1f-4b1c-940f-7c18c5f436ed)

Company: https://www.keypedia.com/companies/etectrx-llc/7584060e-b45f-40c0-b7d0-2d5601e9a6f1

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9