FDA Inspection 997053 — Avanti Polar Lipids
The FDA completed an inspection of Avanti Polar Lipids on November 14, 2016 in Alabaster, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 14, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Alabaster, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1420 | 21 CFR 211.42(c)(9) | Control / Lab Operations Area |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4479 | 21 CFR 108.25(e) | Recall procedures |