FDA Inspection 919211 — Frozen Tropic Cia. Ltda.
The FDA completed an inspection of Frozen Tropic Cia. Ltda. on March 24, 2015 in Quito. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 24, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Quito (Ecuador)
Citations
| ID | CFR | Description |
|---|---|---|
| 12734 | 21 CFR 120.12(a) | Records required - not maintained |
| 12743 | 21 CFR 120.8(b)(4) | HACCP plan - monitoring procedures not adequate |
| 12747 | 21 CFR 120.8(b)(3) | HACCP plan - critical limits not listed or not adequate |
| 12748 | 21 CFR 120.8(b)(5) | HACCP plan - corrective action plan not included |
| 9930 | 21 CFR 120.6(c) | SSOP records |
| 9931 | 21 CFR 120.6(b) | Sanitation monitoring |
| 9955 | 21 CFR 120.11(a)(1) | Verification activities - minimum |
| 9961 | 21 CFR 120.24(a) | Process controls - HACCP plan - 5 log reduction |