FDA Inspection 1017531 — ATSF NE Office
The FDA completed an inspection of ATSF NE Office on March 7, 2017 in Kimberly, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 7, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Kimberly, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12373 | 21 CFR 1271.200(d) | Inspected routinely |
| 12375 | 21 CFR 1271.210(a) | Use prior to verification |