FDA 483 - Christopher T.F. Huang M.D., Inc. dba Advanced Reproductive Center of Hawaii - April 28, 2023

An FDA inspection of Christopher T.F. Huang M.D., Inc. dba Advanced Reproductive Center of Hawaii in Honolulu, HI, identified a significant issue regarding donor screening practices. The firm failed to adequately screen oocyte donors for risk factors and clinical evidence of communicable diseases. Specifically, one donor was not asked a critical question about Syphilis during their medical history interview.