FDA Inspection 871901 — Versiti Wisconsin, Inc
The FDA completed an inspection of Versiti Wisconsin, Inc on Mar 21, 2014 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 21, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Fitchburg, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12332 | 21 CFR 1271.170(b) | Qualifications lacking |
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |