FDA Inspection 851249 — Pure Edge Nutrition LLC.
The FDA completed an inspection of Pure Edge Nutrition LLC. on October 8, 2013 in Toms River, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 8, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Toms River, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15656 | 21 CFR 111.475(a) | Records-holding, distribution: originals, copies, electronic |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |