FDA Inspection 635740 — Kub Technologies, Inc.
The FDA completed an inspection of Kub Technologies, Inc. on December 18, 2009 in Stratford, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 18, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Stratford, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2648 | 21 CFR 820.30(f) | Design verification procedures |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 4071 | 21 CFR 820.30(i) | Design changes - validation vs. verification |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |