FDA Inspection 792313 — NX Generation Ltd.
The FDA completed an inspection of NX Generation Ltd. on July 25, 2012 in Hauppauge, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 25, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15458 | 21 CFR 111.20(d)(1)(i) | Floors, walls, ceilings |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15842 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15989 | 21 CFR 111.127 | Quality control operations - packaging, labeling |
| 16067 | 21 CFR 111.35(b)(1)(ii) | Procedures - equipment; calibrating, inspecting, checking |
| 6552 | 21 CFR 1250.28 | Handling to avoid contamination |