FDA Inspection 714288 — Blue Ocean of Colorado, Inc.
The FDA completed an inspection of Blue Ocean of Colorado, Inc. on March 16, 2011 in Denver, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 16, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1060 | 21 CFR 123.11(a) | SSOP(S) |
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 6001 | 21 CFR 123.11(b) | Sanitation monitoring documentation |
| 6008 | 21 CFR 123.8(a)(3) | Verification - record review - frequency |
| 6019 | 21 CFR 123.8(a)(2) | Ongoing verification - complaints, calibration records |
| 6020 | 21 CFR 123.9(a) | Records - content |
| 904 | 21 CFR 123.6(b) | No HACCP plan |
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |
| 906 | 21 CFR 123.6(b) | HACCP plan location |
| 908 | 21 CFR 123.6(d) | Signed and dated |
| 918 | 21 CFR 123.8(a) | Verification - reviewers qualifications |
| 931 | 21 CFR 123.8(d) | Verification - recordkeeping |