FDA 483 - Center for Reproductive Health Fertility Laboratory of Nashville - June 30, 2022

The FDA issued a Form 483 to Center for Reproductive Health Fertility Laboratory of Nashville following an inspection that identified five significant observations. The firm failed to adequately document HCT/P donor eligibility, maintain complete summary records for donor determinations, and ensure written procedures were available and staff trained. These issues highlight deficiencies in the firm's control over critical aspects of human cell and tissue product processing.