FDA Inspection 696427 — UnitDrugCo., LLC
The FDA completed an inspection of UnitDrugCo., LLC on October 28, 2010 in Centennial, CO. 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
- October 28, 2010
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Centennial, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15381 | 21 CFR 111.8 | Written procedures - hygienic practices |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15740 | 21 CFR 111.210(h)(3)(ii)(A) | Instructions; components; weight, measure |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15752 | 21 CFR 111.210(c) | Master manufacturing record - components; weight, measure |
| 15753 | 21 CFR 111.210(b) | Master manufacturing record - list components |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |