FDA Inspection 926713 — Aegle Nutrition LLC
The FDA completed an inspection of Aegle Nutrition LLC on May 29, 2015 in Carrollton, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 29, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Carrollton, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15559 | 21 CFR 111.260(k)(1) | Batch record - identifier; labels |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 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 |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 16008 | 21 CFR 111.135 | Quality control operations - product complaints; investigate |
| 9935 | 21 CFR 120.7(a) | No hazard analysis |
| 9941 | 21 CFR 120.8(a) | No HACCP plan |