1242642
Simpex Medical Inc — FEI 1000126034
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 28, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fort Mill, SC (United States)
Citations
| ID | CFR | Description |
|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |