FDA Inspection 1118808 — Institute for Human Reproduction (IHR) dba Pinnacle Fertility
The FDA completed an inspection of Institute for Human Reproduction (IHR) dba Pinnacle Fertility on February 25, 2020 in Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 25, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |