FDA Inspection 1064062 — Threshold Enterprises, Ltd.
The FDA completed an inspection of Threshold Enterprises, Ltd. on August 27, 2018 in Scotts Valley, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 27, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Scotts Valley, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15938 | 21 CFR 111.105(f) | Quality control - representative samples |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |