FDA Inspection 1166545 — Baxalta US Inc.
The FDA completed an inspection of Baxalta US Inc. on April 7, 2022 in Thousand Oaks, CA. 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
- April 7, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Thousand Oaks, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |