FDA Inspection 1050728 — Swissray International Inc.
The FDA completed an inspection of Swissray International Inc. on May 4, 2018 in Edison, NJ. 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
- May 4, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3343 | 21 CFR 820.198(e) | Maintained |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |