FDA Inspection 599887 — Blue Ocean of Colorado, Inc.
The FDA completed an inspection of Blue Ocean of Colorado, Inc. on July 22, 2009 in Denver, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 22, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1125 | 21 CFR 110.40(a) | Materials and workmanship |
| 1525 | 21 CFR 123.11(c) | Sanitation Records |
| 1556 | 21 CFR 110.35(b)(2) | Storage requirements |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 1565 | 21 CFR 110.35(d)(3) | Non-food-contact surfaces (S) |
| 3656 | 21 CFR 110.37(d)(3) | Self-closing doors |
| 3661 | 21 CFR 110.37(e)(5) | Signs |
| 6001 | 21 CFR 123.11(b) | Sanitation monitoring documentation |
| 6019 | 21 CFR 123.8(a)(2) | Ongoing verification - complaints, calibration records |
| 6020 | 21 CFR 123.9(a) | Records - content |
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |
| 913 | 21 CFR 123.8(a)(1) | Reassessment of HACCP plan |
| 931 | 21 CFR 123.8(d) | Verification - recordkeeping |
| 933 | 21 CFR 123.8(a)(2)(ii) | Calibration - adequacy |
| 963 | 21 CFR 123.6(c)(5) | Corrective action plan |