FDA Inspection 1192782 — Cooper Institute For Advanced Reproductive Medicine
The FDA completed an inspection of Cooper Institute For Advanced Reproductive Medicine on Dec 9, 2022 in Houston, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 9, 2022
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12250 | 21 CFR 1271.55(d)(4) | Ten year retention |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |