FDA 483 - C.A.R.E. Fertility - October 26, 2023

C.A.R.E. Fertility in Glendale, CA, was cited for significant deficiencies in its human cells, tissues, and cellular and tissue-based products (HCT/P) program. The inspection revealed failures in donor screening for communicable diseases, inadequate donor eligibility procedures, improper quarantine and labeling of HCT/Ps, and insufficient record retention. These issues indicate a lack of control over critical processes for ensuring HCT/P safety.