FDA Inspection 958035 — TechMix LLC
The FDA completed an inspection of TechMix LLC on December 7, 2015 in Fennimore, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 7, 2015
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Fennimore, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15382 | 21 CFR 111.8 | Written procedures - personnel qualifications |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15708 | 21 CFR 111.325(a) | Written procedures, laboratory operations |
| 15743 | 21 CFR 111.210(h)(3) | Master manufacturing record - specific actions; quality |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15775 | 21 CFR 111.415(e) | Dietary supplement containers - mix-ups |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15947 | 21 CFR 111.105(i) | Quality control - required operations product complaints |
| 1698 | 21 CFR 110.80(b)(5) | Work-in-progress |