FDA Inspection 747222 — Potenergy Natural Foods
The FDA completed an inspection of Potenergy Natural Foods on September 27, 2011 in Cambridge, MD. 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
- September 27, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Cambridge, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1642 | 21 CFR 113.100(b) | Review not signed/dated |
| 1643 | 21 CFR 113.100(e) | Incomplete information |
| 1695 | 21 CFR 110.80(b)(2) | Manufacturing conditions |
| 2847 | 21 CFR 113.40(g)(1)(i)(B)(1) | Scale, chart |
| 2869 | 21 CFR 113.40(g)(1)(ii)(E) | TID reading, holding tube outlet - start packaging |
| 2890 | 21 CFR 113.40(g)(2)(i)(A) | Recording device - flow rate, temperature, concentration |
| 2899 | 21 CFR 113.40(g)(2)(ii)(C) | Operating conditions - observed, recorded |