FDA Inspection 1179911 — BAXALTA US INC.
The FDA completed an inspection of BAXALTA US INC. on Sep 15, 2022 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 15, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Round Lake, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1846 | 21 CFR 211.84(d)(3) | Establish reliability of supplier's C of A |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |