FDA Inspection 979961 — TAKARA BELMONT CORPORATION
The FDA completed an inspection of TAKARA BELMONT CORPORATION on Jul 21, 2016 in Osaka. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 21, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Osaka (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |