FDA Inspection 825571 — Greenland Inc
The FDA completed an inspection of Greenland Inc on Mar 15, 2013 in Seattle, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 15, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Seattle, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1486 | 21 CFR 113.87(b) | Retort room: traffic control system not established |
| 15352 | FDCA 761(b)(1) | No label copy submitted with AE report (dietary supplement) |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15784 | 21 CFR 111.410(c) | Packaging, labels - master manufacturing record |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15921 | 21 CFR 111.95(b)(2) | Documentation - supplier qualification |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |