FDA Inspection 813531 — Reproductive Medicine Institute
The FDA completed an inspection of Reproductive Medicine Institute on Jan 18, 2013 in Bloomingdale, IL. 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
- Jan 18, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Bloomingdale, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |