FDA Inspection 1218525 — QUICKSILVER SCIENTIFIC, INC
The FDA completed an inspection of QUICKSILVER SCIENTIFIC, INC on Sep 21, 2023 in Louisville, CO. 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
- Sep 21, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Louisville, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |