FDA Inspection 1021240 — X TECH CO-PACKERS, LLC
The FDA completed an inspection of X TECH CO-PACKERS, LLC on August 9, 2017 in Orem, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 9, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Orem, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16054 | 21 CFR 111.535(a) | Records-Rtn'd dietary supplement: originals, copies, elec |