FDA Inspection 981757 — Serramonte Enterprise
The FDA completed an inspection of Serramonte Enterprise on July 5, 2016 in San Juan. 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 5, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- San Juan (Philippines)
Citations
| ID | CFR | Description |
|---|---|---|
| 12745 | 21 CFR 120.8(b)(1) | HACCP plan - food hazards not listed |
| 12748 | 21 CFR 120.8(b)(5) | HACCP plan - corrective action plan not included |
| 12749 | 21 CFR 120.8(b)(6) | HACCP plan - verify procedures / frequency - none listed |
| 9930 | 21 CFR 120.6(c) | SSOP records |
| 9943 | 21 CFR 120.8(a) | HACCP plan - location and type of juice |
| 9953 | 21 CFR 120.11(a)(1)(iv)(A) | CCP record review adequacy |