FDA Inspection 1333720 — OSCILLA A/S
The FDA completed an inspection of OSCILLA A/S on Sep 1, 2026 in Aarhus N. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 1, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Aarhus N (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 23259 | ISO 13485:2016 Clause 8.5.2 | Corrective action records not maintained |