FDA Inspection 763185 — Keystone Industries
The FDA completed an inspection of Keystone Industries on January 23, 2012 in Cherry Hill, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 23, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cherry Hill, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3696 | 21 CFR 820.100(b) | Documentation |