Arizona Center for Reproductive Endocrinology & InfertilityJune 28, 2023

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

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Record Details

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.

Company: Arizona Center for Reproductive Endocrinology & Infertility
Inspection Date: June 28, 2023
Product Type: Biologics
Office: Division of Pharmaceutical Quality Operations IV
People: Sunitha K. Rajaram (issuing_officer)
Emily S. McGann

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ID · a55eee0c-abfe-47af-8646-8cc251ccd110