FDA Inspection 1270789 — Sabre Medical Pty. Ltd.
The FDA completed an inspection of Sabre Medical Pty. Ltd. on May 22, 2025 in Lane Cove West. 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 22, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lane Cove West (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |