FDA Inspection 1062626 — Confidence U.S.A. Inc.
The FDA completed an inspection of Confidence U.S.A. Inc. on August 10, 2018 in Port Washington, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 10, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Port Washington, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15627 | 21 CFR 111.180(b)(3) | Documentation - product received; packaging, labeling |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 15951 | 21 CFR 111.110(c) | Quality control operations - tests, examinations; results |