FDA Inspection 881331 — CT Concerns, Inc.
The FDA completed an inspection of CT Concerns, Inc. on June 16, 2014 in San Diego, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 16, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 10005 | n/a | Procedural requirements |
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 1695 | 21 CFR 110.80(b)(2) | Manufacturing conditions |
| 6008 | 21 CFR 123.8(a)(3) | Verification - record review - frequency |
| 6010 | 21 CFR 123.8(a)(3)(i) | Monitoring record review adequacy |
| 904 | 21 CFR 123.6(b) | No HACCP plan |
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |