FDA Inspection 759525 — Institute for Human Reproduction (IHR) dba Pinnacle Fertility
The FDA completed an inspection of Institute for Human Reproduction (IHR) dba Pinnacle Fertility on May 10, 2012 in Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 10, 2012
- Fiscal Year
- 2012
- 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 |
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12490 | 21 CFR 1271.85(b)(1) | Cell-associated CD |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |