FDA Inspection 1042241 — Shent USA, Inc.
The FDA completed an inspection of Shent USA, Inc. on February 23, 2018 in Northborough, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 23, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Northborough, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |