FDA Inspection 1066564 — 21St Century Scientific Inc
The FDA completed an inspection of 21St Century Scientific Inc on Sep 12, 2018 in Coeur d Alene, ID. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 12, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Coeur d Alene, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |