FDA Inspection 1229268 — Vesta Pharmaceuticals, Inc.
The FDA completed an inspection of Vesta Pharmaceuticals, Inc. on February 9, 2024 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 9, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15562 | 21 CFR 111.260(l)(1) | Batch record - quality control review; production |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15967 | 21 CFR 111.117(b) | Quality control operations - calibration records |