483
Center for Reproductive Health Fertility Laboratory of NashvilleFDA 483 - Center for Reproductive Health Fertility Laboratory of Nashville - February 23, 2024
Record Details
The Center for Reproductive Health Fertility Laboratory of Nashville received a Form 483 following an inspection from February 22-23, 2024. The inspection revealed a significant issue with record-keeping for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Specifically, donor names were improperly included in the records of eight anonymous oocyte donors.
- Inspection date
- February 23, 2024
- Product type
- biologics
- Person
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ID · 9c8c3f83-a139-45ea-afa7-397be9916b0e
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