FDA Inspection 601117 — Avole, Inc.
The FDA completed an inspection of Avole, Inc. on July 23, 2009 in San Sebastian, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 23, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- San Sebastian, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1172 | 21 CFR 110.40(e) | Lack of thermometer |
| 1427 | 21 CFR 110.20(b)(5) | Safety lighting and glass |
| 1525 | 21 CFR 123.11(c) | Sanitation Records |
| 6021 | 21 CFR 123.10 | HACCP training or qualification |
| 901 | 21 CFR 123.6(a) | Hazard analysis |
| 904 | 21 CFR 123.6(b) | No HACCP plan |