FDA 483 - American Reproductive Centers, Inc. - February 22, 2019

American Reproductive Centers, Inc. in Costa Mesa, CA, received a Form FDA 483 for deficiencies in its human reproductive tissue operations. The inspection revealed that oocyte donors were not adequately screened for communicable disease agents and diseases, including Zika and West Nile Virus, due to insufficient questionnaires. Furthermore, the firm lacked defined, documented, and revised procedures for screening and determining donor eligibility of HCT/Ps.