FDA Inspection 1058966 — Intelligent Implant Systems
The FDA completed an inspection of Intelligent Implant Systems on Jul 16, 2018 in Charlotte, NC. 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 16, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |