FDA Inspection 848340 — Advanced Reproductive Health Centers LTD, Chicago IVF
The FDA completed an inspection of Advanced Reproductive Health Centers LTD, Chicago IVF on September 18, 2013 in Valparaiso, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 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 |