FDA Inspection 835934 — EonNutra, LLC
The FDA completed an inspection of EonNutra, LLC on June 10, 2013 in Colorado Springs, CO. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 10, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Colorado Springs, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15954 | 21 CFR 111.113(a)(2) | Quality control master manufacturing record; material review, disposition |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |
| 1689 | 21 CFR 110.80 | Reasonable precautions |