Etex Corporation – FDA 483, 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.
ID · 1b0d65ae-6414-48d4-be19-9379eb6e69f7
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