FDA Inspection 1237992 — Afton Scientific, LLC
The FDA completed an inspection of Afton Scientific, LLC on May 8, 2024 in Charlottesville, VA. 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
- May 8, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Charlottesville, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1846 | 21 CFR 211.84(d)(3) | Establish reliability of supplier's C of A |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |