FDA Inspection 1026106 — STRYKER (SUZHOU) MEDICAL TECHNOLOGY CO., LTD.
The FDA completed an inspection of STRYKER (SUZHOU) MEDICAL TECHNOLOGY CO., LTD. on August 24, 2017 in Suzhou. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 24, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Suzhou (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3696 | 21 CFR 820.100(b) | Documentation |