FDA Inspection 1221029 — Institute for Human Reproduction (IHR) dba Pinnacle Fertility
The FDA completed an inspection of Institute for Human Reproduction (IHR) dba Pinnacle Fertility on October 25, 2023 in Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 25, 2023
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12231 | 21 CFR 1271.50(b)(1) | Donor screening standards |
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |