FDA Inspection 651933 — Dio Corporation
The FDA completed an inspection of Dio Corporation on Feb 11, 2010 in Haeundae. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 11, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Haeundae (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 3288 | 21 CFR 820.90(b)(1) | Documentation of disposition, justification, signature |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |