Arizona Center for Reproductive Endocrinology & Infertility – FDA 483, Jun 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.
- Inspection date
- June 28, 2023
- Product type
- biologics
ID · a55eee0c-abfe-47af-8646-8cc251ccd110
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