FDA Inspection 1256400 — American Softgels, Inc.
The FDA completed an inspection of American Softgels, Inc. on December 12, 2024 in Loyalhanna, PA. 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
- December 12, 2024
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Loyalhanna, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22811 | 21 CFR 111.453 | Written procedures - establish; holding and distribution |
| 22834 | 21 CFR 111.25 | Equipment - establish written procedures |
| 22843 | 21 CFR 111.70(b) | Specifications - components |