FDA Inspection 930407 — Cortek Endoscopy Inc
The FDA completed an inspection of Cortek Endoscopy Inc on Jun 16, 2015 in Wauconda, IL. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 16, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wauconda, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |