FDA Inspection 951096 — Excellence Medical Supplies Co., Ltd.
The FDA completed an inspection of Excellence Medical Supplies Co., Ltd. on November 12, 2015 in Changzhou. 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
- November 12, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Changzhou (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |