FDA 483 - Alfred J. Rodriguez, M.D., P.A. - February 27, 2024

An FDA inspection of Alfred J. Rodriguez, M.D., P.A., a reproductive clinic in Plano, TX, revealed significant deficiencies in their HCT/P donor screening and testing processes. The firm failed to ensure donor eligibility through adequate screening questionnaires and proper documentation. Additionally, their standard operating procedures for donor testing were found to be incomplete, omitting crucial communicable disease tests.