FDA Inspection 1246527 — Pure Tropic
The FDA completed an inspection of Pure Tropic on August 14, 2024 in Chengappalli. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 14, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Chengappalli (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1045 | 21 CFR 113.10 | Supervisors |
| 1483 | 21 CFR 113.87(a) | Operating processes not posted |
| 16452 | 21 CFR 113.40(g)(1)(i)(A)(4) | Aseptic processing: TID not accurate to 1° F |
| 18154 | 21 CFR 117.80(a)(2) | Appropriate quality control operations |
| 2838 | 21 CFR 113.40(g)(1)(i)(A) | No accurate TID |
| 2844 | 21 CFR 113.40(g)(1)(i)(B) | Present each sterilizer, accurate |
| 2860 | 21 CFR 113.40(g)(1)(i)(F) | Unauthorized flow adjustments |
| 2890 | 21 CFR 113.40(g)(2)(i)(A) | Recording device - flow rate, temperature, concentration |