FDA Inspection 675303 — Potenergy Natural Foods
The FDA completed an inspection of Potenergy Natural Foods on Jul 29, 2010 in Cambridge, MD. 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). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 29, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Cambridge, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1303 | 21 CFR 113.81(f) | Critical Factors |
| 1330 | 21 CFR 113.100(a) | Process records - forms missing information |
| 1641 | 21 CFR 113.100(b) | Review not timely |
| 1642 | 21 CFR 113.100(b) | Review not signed/dated |
| 1643 | 21 CFR 113.100(e) | Incomplete information |
| 2361 | 21 CFR 110.80 | Testing |
| 2837 | 21 CFR 113.40(g)(4) | Critical factors record - frequency |
| 2889 | 21 CFR 113.40(g)(2)(i)(A) | Instrumented - container closure sterilization |
| 2890 | 21 CFR 113.40(g)(2)(i)(A) | Recording device - flow rate, temperature, concentration |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 4179 | 21 CFR 113.83 | Records of process establishment |
| 4515 | 21 CFR 108.35(c)(2) | Process filing |