FDA Inspection 957248 — Vale Enterprises, Incorporated
The FDA completed an inspection of Vale Enterprises, Incorporated on August 27, 2015 in Denver, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 27, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15836 | 21 CFR 111.70(c)(3) | QC specification, identity, purity, strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |