FDA Inspection 906378 — Xin Hua International Biological, LLC
The FDA completed an inspection of Xin Hua International Biological, LLC on December 5, 2014 in Conway, AR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 5, 2014
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Conway, AR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 15995 | 21 CFR 111.127(d) | Quality control operations - packaged, labeled; specifications |