FDA Inspection 1156287 — Alaska Spring Pharmaceuticals Inc.
The FDA completed an inspection of Alaska Spring Pharmaceuticals Inc. on November 9, 2021 in Westbury, NY. 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: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 9, 2021
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Westbury, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15542 | 21 CFR 111.260(b) | Batch record - date, time; maintenance |
| 15673 | 21 CFR 111.315(a) | Criteria for establishing specifications |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15979 | 21 CFR 111.123(a)(3) | Quality control monitoring; production, process control system |