FDA Inspection 836637 — Advanced Institute for Infertility, S.C.
The FDA completed an inspection of Advanced Institute for Infertility, S.C. on June 21, 2013 in Chicago, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 21, 2013
- Fiscal Year
- 2013
- 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 |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |