FDA Inspection 1092986 — Afton Scientific, LLC
The FDA completed an inspection of Afton Scientific, LLC on Jun 14, 2019 in Charlottesville, VA. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 14, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Charlottesville, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4404 | 21 CFR 211.194(a)(1) | Sample identification and other information |