FDA Inspection 1019907 — Qualitech Pharma Co., Ltd. - Shiga Plant
The FDA completed an inspection of Qualitech Pharma Co., Ltd. - Shiga Plant on July 31, 2017 in Yasu. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 31, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Yasu (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |