FDA Inspection 848340 — Advanced Reproductive Health Centers LTD, Chicago IVF
The FDA completed an inspection of Advanced Reproductive Health Centers LTD, Chicago IVF on Sep 18, 2013 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 18, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Valparaiso, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |
| 12290 | 21 CFR 1271.80(d)(1) | Reactive tests--not determined ineligible |