FDA Inspection 918159 — Avole, Inc.
The FDA completed an inspection of Avole, Inc. on March 20, 2015 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). 2 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 20, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- San Sebastian, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 6010 | 21 CFR 123.8(a)(3)(i) | Monitoring record review adequacy |
| 913 | 21 CFR 123.8(a)(1) | Reassessment of HACCP plan |