FDA Inspection 1018102 — University of Louisville Physicians OBGYN & Womens Health Fertility Center
The FDA completed an inspection of University of Louisville Physicians OBGYN & Womens Health Fertility Center on July 14, 2017 in Louisville, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 14, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |