FDA Inspection 1233747 — SpineCraft, LLC.
The FDA completed an inspection of SpineCraft, LLC. on Mar 22, 2024 in Westmont, 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
- Mar 22, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Westmont, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 642 | 21 CFR 803.18(b)(1)(i) | Adverse events--all info not in file |