Women's Fertility and Health Center – FDA 483, Apr 19, 2019
The FDA issued a Form 483 to Women's Fertility and Health Center following an inspection of their human reproductive tissue establishment. The inspection revealed significant deficiencies in donor screening for communicable disease risks, a lack of established procedures for donor eligibility determination, and failures in proper identification and labeling of HCT/Ps. These issues indicate a potential risk to the safety and quality of human cells, tissues, and cellular and tissue-based products.
ID · 732d8661-51af-4294-8704-6642b08165a0
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