FDA 483 - John Kumar Jain MD Inc. - February 08, 2019

An FDA inspection of John Kumar Jain MD Inc., a reproductive establishment in Santa Monica, CA, on February 7-8, 2019, identified one observation. The firm failed to adequately screen donors for communicable disease agents, specifically regarding Zika virus, due to deficiencies in their donor screening questionnaire. This indicates a significant lapse in donor eligibility determination processes.