FDA Inspection 1319172 — Nipro (Thailand) Corporation Limited
The FDA completed an inspection of Nipro (Thailand) Corporation Limited on May 28, 2026 in Sena. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 28, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sena (Thailand)
Citations
| ID | CFR | Description |
|---|---|---|
| 23077 | ISO 13485:2016 Clause 6.3 | Requirements for infrastructure maintenance activities not documented |