483
Fertility Answers LLCFertility Answers LLC – FDA 483, Dec 6, 2022
Record Details
Fertility Answers LLC in Lafayette, LA, received a Form FDA 483 for deficiencies in donor screening and eligibility determination for human cells, tissues, and cellular and tissue-based products (HCT/Ps). The inspection revealed failures to screen for Zika virus risk factors, properly document donor eligibility, and ensure communicable disease testing was performed by a CLIA-certified laboratory. These observations indicate a need for improved donor qualification processes.
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ID · 419c2a3b-4247-4d73-8077-7cc706927d28
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