# FDA 483 - Cupron Inc. - September 19, 2019

Source: https://www.globalkeysolutions.net/records/483/cupron-inc/63e4fc1a-992a-4cbe-9e4f-1fe637412057

> FDA 483 for Cupron Inc. on September 19, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Cupron Inc.
- Inspection Date: 2019-09-19
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Cupron Inc. in Richmond, VA, was inspected by the FDA, revealing a significant deficiency in its complaint handling system. The firm failed to establish proper procedures for receiving, reviewing, and evaluating complaints related to its patient gowns, bed sheets, and blankets. This indicates a lack of a formally designated unit and established processes for managing product complaints.

## Related Officers

- [Tiki Dixon](https://www.globalkeysolutions.net/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.globalkeysolutions.net/companies/cupron-inc/bd5177aa-91ab-456b-892c-c708f0b9b994

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e