FDA Inspection 1239342 — Fysicon BV
The FDA completed an inspection of Fysicon BV on May 24, 2024 in Oss. 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 24, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oss (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |