FDA Inspection 1219743 — Afton Scientific, LLC
The FDA completed an inspection of Afton Scientific, LLC on October 6, 2023 in Charlottesville, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 6, 2023
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Charlottesville, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 22714 | 21 CFR 117.410(c) | Supply-chain program - Assurance (Adequate) |
| 22720 | 21 CFR 117.135(c)(3) | Sanitation preventive controls - Appropriate (Adequate) |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |