FDA Inspection 1229880 — Aegle Nutrition LLC
The FDA completed an inspection of Aegle Nutrition LLC on March 6, 2024 in Carrollton, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 6, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Carrollton, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |