FDA Inspection 838732 — Vale Enterprises, Incorporated
The FDA completed an inspection of Vale Enterprises, Incorporated on June 24, 2013 in Denver, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 24, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15433 | 21 CFR 111.15(d)(1) | Animals and pests in facility |
| 15480 | 21 CFR 111.20(h) | Physical plant - screening against pests |
| 15652 | 21 CFR 111.465(b) | Retain reserve samples - 1 year, 2 years |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15799 | 21 CFR 111.560(a)(1) | Product complaint - quality control review |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |