FDA Inspection 734305 — Merits Health Products Co., Ltd.
The FDA completed an inspection of Merits Health Products Co., Ltd. on July 14, 2011 in Taichung. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 14, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Taichung (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |