FDA 483 - Etex Corporation - May 23, 2019

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.