FDA Inspection 966213 — Confidence U.S.A. Inc.
The FDA completed an inspection of Confidence U.S.A. Inc. on April 12, 2016 in Port Washington, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 12, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Port Washington, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15689 | 21 CFR 111.315(b)(3) | Sampling plans; finished batches |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 16037 | 21 CFR 111.605 | Records - keep: 1 year, 2 years |