FDA 483 - Reproductive Technologies, Inc. - August 16, 2019

An FDA inspection of Reproductive Technologies, Inc. in Berkeley, CA, revealed significant deficiencies in their human reproductive tissue operations. The firm failed to properly determine donor eligibility, adequately screen for communicable disease risks like HIV, Hepatitis B, Zika, and West Nile Virus, and maintain complete records for distributed semen. These issues indicate a serious lack of control over the safety and quality of their distributed HCT/Ps.