FDA 483 - Pacific Reproductive Center - January 13, 2025

Pacific Reproductive Center, Inc. in Torrance, CA, was inspected regarding its HCT/P reproductive establishment. The inspection revealed significant deficiencies in donor screening, eligibility determination, record-keeping, and labeling practices, particularly concerning communicable disease risks like West Nile Virus. These issues indicate a lack of adequate controls to ensure donor safety and product integrity.