FDA Inspection 1268745 — Life Spine, Inc.
The FDA completed an inspection of Life Spine, Inc. on May 2, 2025 in Huntley, IL. 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 2, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Huntley, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |