FDA 483 - Cooper Institute for Advanced Reproductive Medicine - November 16, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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