FDA Inspection 1242642 — Simpex Medical Inc
The FDA completed an inspection of Simpex Medical Inc on Jun 28, 2024 in Fort Mill, SC. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 28, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |