FDA Inspection 1010805 — Threshold Enterprises, Ltd.
The FDA completed an inspection of Threshold Enterprises, Ltd. on April 25, 2017 in Scotts Valley, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 25, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Scotts Valley, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15660 | 21 CFR 111.475(b)(2) | Records - product distribution |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15834 | 21 CFR 111.70(c)(2) | Specifications identity, purity strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 16043 | 21 CFR 111.503 | Written procedures - returned dietary supplement; destroyed |
| 16056 | 21 CFR 111.535(a) | Records - returned dietary supplement: readily available |