FDA 483 - Southern California Center for Reproductive Medicine - January 20, 2023

The FDA issued a Form 483 to Southern California Center for Reproductive Medicine, a reproductive fertility center in Newport Beach, CA, following an inspection. The inspection revealed significant deficiencies in donor screening for communicable diseases, including West Nile Virus, HIV, Hepatitis B, and CJD/TSE. Additionally, the firm lacked adequate procedures for donor eligibility and failed to maintain donor anonymity in accompanying records.