FDA 483 - Envita Fertility Center - October 06, 2023

Envita Fertility Center underwent an FDA inspection from October 5-6, 2023, which resulted in the issuance of an FDA Form 483. This document outlines observations regarding conditions and practices at the HCT/P Reproductive Fertility Center. A primary observation noted that records for human cells, tissues, and cellular and tissue-based products (HCT/Ps) contained personally identifiable information for donors, including names and dates of birth, even for anonymous oocyte donors. This practice, observed in numerous records from June 2022 to October 2023, raises concerns about donor anonymity and record-keeping integrity. Additionally, the firm's donor eligibility procedures were not adequately reviewed and approved by a responsible person, specifically the current Medical Director, prior to their implementation. Since June 2023, the Medical Director has been screening and determining donor eligibility using protocols that lacked proper review and approval, highlighting a procedural oversight in quality management. These observations indicate potential deviations from established good tissue practices (GTP) designed to ensure product safety and quality. Envita Fertility Center is expected to review these findings, investigate their root causes, and implement comprehensive corrective and preventive actions to address the identified issues and ensure compliance with regulatory requirements.