FDA Inspection 1004243 — UnitDrugCo., LLC
The FDA completed an inspection of UnitDrugCo., LLC on December 20, 2016 in Centennial, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 20, 2016
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Centennial, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1005 | 21 CFR 110.10(b)(7) | Storage of personal items |
| 1403 | 21 CFR 110.10(b)(4) | Hand jewelry - remove/cover |
| 1405 | 21 CFR 110.10(b)(6) | Failure to wear |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15551 | 21 CFR 111.260(j)(1) | Batch record - date, each step |
| 15559 | 21 CFR 111.260(k)(1) | Batch record - identifier; labels |
| 1562 | 21 CFR 110.35(d) | Failure to clean - general |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 3658 | 21 CFR 110.37(e)(2) | Hand cleaning and sanitizing preparations |