FDA Inspection 734884 — Trace Minerals Opco LLC
The FDA completed an inspection of Trace Minerals Opco LLC on June 22, 2011 in West Haven, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 22, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- West Haven, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1129 | 21 CFR 110.40(a) | Food-contact - corrosion resistant |
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 15938 | 21 CFR 111.105(f) | Quality control - representative samples |