FDA Inspection 656994 — Megagen Implant Co., Ltd.
The FDA completed an inspection of Megagen Implant Co., Ltd. on Apr 1, 2010 in Gyeongsan. 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
- Apr 1, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Gyeongsan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 538 | 21 CFR 820.70(a) | Process control procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |