FDA Inspection 612109 — E. Excel USA, LLC
The FDA completed an inspection of E. Excel USA, LLC on September 10, 2009 in Sandy, UT. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 10, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Sandy, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15545 | 21 CFR 111.260(e) | Batch record - component; identity, weight |
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15677 | 21 CFR 111.315(b)(1) | Sampling plans; components |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |