FDA Inspection 968167 — Threshold Enterprises, Ltd.
The FDA completed an inspection of Threshold Enterprises, Ltd. on April 20, 2016 in Scotts Valley, CA. 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
- April 20, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Scotts Valley, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15430 | 21 CFR 111.15(k) | Sanitation supervisors - qualified |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15801 | 21 CFR 111.560(b) | Quality control, review, approve; investigate, follow-up |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |