FDA 483 - CCRM New York - August 21, 2019

CCRM New York, a human reproductive tissue establishment, was inspected by the FDA, revealing two significant observations. The firm failed to adequately screen oocyte donors for communicable disease risks, specifically Zika virus, and lacked established procedures for donor eligibility determination and identification coding. These issues indicate deficiencies in donor screening and procedural controls for human cells, tissues, and cellular and tissue-based products (HCT/Ps).