FDA Inspection 886063 — AK Biopharm Co., Ltd.
The FDA completed an inspection of AK Biopharm Co., Ltd. on July 4, 2014 in Nam. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 4, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Nam (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 15465 | 21 CFR 111.20(d)(2) | Air blowing equipment |
| 15537 | 21 CFR 111.255(d) | Batch record - electronic |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |