FDA 483 - Stony Brook Community Medical PC - Island Fertility - July 30, 2021
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An FDA inspection of Stony Brook Community Medical PC - Island Fertility, a reproductive human tissue establishment, revealed significant deficiencies in donor eligibility determination. The firm failed to properly screen and test HCT/P donors for communicable diseases and infectious agents, and its procedures for donor eligibility were inadequate. Additionally, HCT/Ps that did not meet eligibility requirements were transferred to other facilities without proper warning labels.
- Inspection Date
- July 30, 2021
- Product Type
- Biologics
ID · 8b8a4287-7a16-42d8-af8e-44495f3bf16e