FDA Inspection 962501 — New Horizon Nutraceuticals LLC
The FDA completed an inspection of New Horizon Nutraceuticals LLC on February 8, 2016 in Kennett Square, PA. 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
- February 8, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Kennett Square, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15493 | 21 CFR 111.25(b) | Procedures - calibrating automated, mechanical equip |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15716 | 21 CFR 111.375(a) | Records - manufacturing operation: readily available |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |