FDA Inspection 857651 — UnitDrugCo., LLC
The FDA completed an inspection of UnitDrugCo., LLC on December 12, 2013 in Centennial, CO. 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: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 12, 2013
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Centennial, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15890 | 21 CFR 111.80(a) | Components packaging, labels used |
| 15954 | 21 CFR 111.113(a)(2) | Quality control master manufacturing record; material review, disposition |
| 15972 | 21 CFR 111.120(b) | Quality control operations - specifications; components, packaging, labels |
| 15978 | 21 CFR 111.123(a)(2) | Quality control operations - batch production records |
| 16058 | 21 CFR 111.535(b)(2) | Records - ret'nd dietary supplement: material review, dispos |