FDA Inspection 789036 — DC Nutrition, Inc.
The FDA completed an inspection of DC Nutrition, Inc. on June 28, 2012 in Wheat Ridge, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 28, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Wheat Ridge, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15455 | 21 CFR 111.20(a) | Physical plant - size, construction, design |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component 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 |
| 15870 | 21 CFR 111.75(c)(1) | Specifications met - verify; production, process control |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |