# FDA 483 - Etex Corporation - May 23, 2019

Source: https://www.keypedia.com/records/483/etex-corporation/1b0d65ae-6414-48d4-be19-9379eb6e69f7

> FDA 483 for Etex Corporation on May 23, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Etex Corporation
- Inspection Date: 2019-05-23
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Etex Corporation in Braintree, MA, a human tissue firm and device manufacturer, revealed a significant issue regarding the documentation accompanying Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Specifically, the firm's EquivaBone product was distributed without the required Summary of Records Report for donor-eligibility determination. Additionally, the product's Instruction for Use (IFU) failed to include a complete listing and interpretation of communicable disease test results and the name and address of the establishment that made the donor-eligibility determination.

## Related Officers

- [Engineer/Investigator](https://www.keypedia.com/people/elizabeth-b-griffin/5567685a-c657-4710-afee-e7af8875b605)

Company: https://www.keypedia.com/companies/etex-corporation/0026be3f-54ba-49cd-8f79-b687c9d4353b

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94