FDA Inspection 917119 — Merits Healthcare Industries (Suzhou) Co., Ltd.
The FDA completed an inspection of Merits Healthcare Industries (Suzhou) Co., Ltd. on Feb 5, 2015 in Suzhou. 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
- Feb 5, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Suzhou (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |