FDA Inspection 771740 — Versiti Wisconsin, Inc
The FDA completed an inspection of Versiti Wisconsin, Inc on Mar 7, 2012 in Fitchburg, WI. 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
- Mar 7, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Fitchburg, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12322 | 21 CFR 1271.160(b)(4) | Training of personnel |
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |