FDA Inspection 562099 — Food Concepts, Incorporated
The FDA completed an inspection of Food Concepts, Incorporated on February 2, 2009 in Lakewood, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 2, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Lakewood, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1306 | 21 CFR 110.20(b)(7) | Screening |
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 1578 | 21 CFR 110.37(f) | Odor, attractant for pests, harborage |
| 1701 | 21 CFR 110.80(b)(7) | Equipment, containers, utensils |
| 3071 | 21 CFR 114.80(a)(1) | Scheduled process |
| 3089 | 21 CFR 114.100(c) | Process deviations- identification and records |
| 6008 | 21 CFR 123.8(a)(3) | Verification - record review - frequency |
| 6018 | 21 CFR 123.7(a) | Corrective action per predetermined plan |
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |
| 933 | 21 CFR 123.8(a)(2)(ii) | Calibration - adequacy |