FDA Inspection 831058 — Louisville Reproductive Center
The FDA completed an inspection of Louisville Reproductive Center on May 6, 2013 in Louisville, KY. 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
- May 6, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |