FDA Inspection 969822 — Daeeun Bio Co Ltd
The FDA completed an inspection of Daeeun Bio Co Ltd on May 13, 2016 in Paju. 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). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 13, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Paju (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 3073 | 21 CFR 114.80(a)(2) | pH testing |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 3086 | 21 CFR 114.100(b) | Maintenance of processing and production records |
| 3658 | 21 CFR 110.37(e)(2) | Hand cleaning and sanitizing preparations |
| 3659 | 21 CFR 110.37(e)(3) | Hand drying |
| 4511 | 21 CFR 108.25(f) | Approved school |