FDA 483 - ALLcare Fertility Center - November 06, 2024

ALLCARE Fertility Center in New York, NY, was cited for multiple deficiencies related to donor eligibility determination and screening for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The inspection revealed failures in documenting donor eligibility, collecting specimens at appropriate times for communicable disease testing, and maintaining adequate procedures for donor screening. Additionally, the firm failed to properly label HCT/Ps not requiring donor eligibility determination and maintained inaccurate donor eligibility records.