FDA Inspection 723121 — Food Concepts, Incorporated
The FDA completed an inspection of Food Concepts, Incorporated on April 28, 2011 in Lakewood, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 28, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Lakewood, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1125 | 21 CFR 110.40(a) | Materials and workmanship |
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1287 | 21 CFR 110.20(a)(1) | Harborage areas |
| 1554 | 21 CFR 110.35(a) | Cleaning and sanitizing operations |
| 1570 | 21 CFR 110.35(d)(5) | Safe and adequate for use |
| 2391 | 21 CFR 110.80(a)(6) | Thawed appropriately |
| 3071 | 21 CFR 114.80(a)(1) | Scheduled process |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 908 | 21 CFR 123.6(d) | Signed and dated |
| 960 | 21 CFR 123.6(c)(2) | Critical control points |
| 961 | 21 CFR 123.6(c)(3) | Critical limits |
| 963 | 21 CFR 123.6(c)(5) | Corrective action plan |