FDA Inspection 804166 — Excelsior Alchemy, Inc.
The FDA completed an inspection of Excelsior Alchemy, Inc. on October 22, 2012 in Tempe, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 22, 2012
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Tempe, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15403 | 21 CFR 111.12(b) | Personnel - quality control operations; responsibilities |
| 15589 | 21 CFR 111.160(c) | Packaging, labels - quarantine |
| 15665 | 21 CFR 111.303 | Written procedures - tests, examinations; specifications met |
| 15675 | 21 CFR 111.315(b) | Sampling plans; establish, follow |
| 15715 | 21 CFR 111.375(b) | Records - manufacturing operations; written procedures |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |