FDA Inspection 700144 — Columbine Specialty Products, Inc
The FDA completed an inspection of Columbine Specialty Products, Inc on December 10, 2010 in Denver, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 10, 2010
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15443 | 21 CFR 111.15(b)(2) | Physical plant - repair |
| 15529 | 21 CFR 111.30(e) | Equipment - controls, intended use |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15623 | 21 CFR 111.180(b)(2) | Records - receiving; components, packaging, labels, products |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15891 | 21 CFR 111.80(a) | Components packaging, labels received |