FDA Inspection 1018921 — Aktina Medical Corp
The FDA completed an inspection of Aktina Medical Corp on July 24, 2017 in Congers, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 24, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Congers, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3696 | 21 CFR 820.100(b) | Documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |