FDA Inspection 1200022 — ALBA Bioscience Limited
The FDA completed an inspection of ALBA Bioscience Limited on March 17, 2023 in Penicuik. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 17, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Penicuik (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |