FDA Inspection 925291 — Pure Tropic
The FDA completed an inspection of Pure Tropic on Apr 30, 2015 in Chengappalli. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 30, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Chengappalli (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 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 |
| 2840 | 21 CFR 113.40(g)(1)(i)(A) | TID accuracy test frequency |
| 2844 | 21 CFR 113.40(g)(1)(i)(B) | Present each sterilizer, accurate |
| 2869 | 21 CFR 113.40(g)(1)(ii)(E) | TID reading, holding tube outlet - start packaging |