Cooper Institute for Advanced Reproductive Medicine – FDA 483, Nov 16, 2023
The Cooper Institute for Advanced Reproductive Medicine in Houston, TX, received a Form FDA 483 with 11 observations following an inspection from November 13-16, 2023. The inspection revealed significant deficiencies in donor eligibility determination, screening, testing, labeling, record-keeping, and the establishment of required procedures for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Several observations, including failures in donor screening, establishing procedures, and indelible records, were noted as repeat issues.
- Inspection date
- November 16, 2023
- Product type
- other
ID · 7781667f-1adf-42ef-be5c-df90023c96f1
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