FDA Inspection 1103189 — BAXALTA US INC.
The FDA completed an inspection of BAXALTA US INC. on Sep 25, 2019 in Round Lake, IL. 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
- Sep 25, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Round Lake, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3465 | 21 CFR 640.81(c) | Microbial contamination |
| 6011 | 21 CFR 123.8(a)(3)(ii) | Corrective action record review adequacy |
| 6801 | 21 CFR 807.22(a) | Initial registration and listing |