FDA Inspection 888714 — Alken Inc.
The FDA completed an inspection of Alken Inc. on July 24, 2014 in Colchester, VT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 24, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Colchester, VT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 5005 | 21 CFR 1002.11 | Failure to submit |