FDA Inspection 1058816 — Signature Orthopedics Pty Limited
The FDA completed an inspection of Signature Orthopedics Pty Limited on Jul 5, 2018 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 5, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lane Cove West (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |