FDA Inspection 1209490 — Advanced Reproductive Health Centers LTD, Chicago IVF
The FDA completed an inspection of Advanced Reproductive Health Centers LTD, Chicago IVF on Jul 5, 2023 in Valparaiso, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 5, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Valparaiso, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |