FDA 483 - Arizona Center for Reproductive Endocrinology & Infertility - June 28, 2023

The FDA inspected Arizona Center for Reproductive Endocrinology & Infertility in Tucson, AZ, and found significant deficiencies in their donor screening and testing procedures for reproductive tissues. Observations included using non-FDA-approved tests, inadequate donor medical screening, improper specimen collection timing, and failures in record-keeping and procedure documentation for communicable disease risks. Several observations were repeats, indicating persistent issues with compliance.