FDA Inspection 677920 — Burke, Inc.
The FDA completed an inspection of Burke, Inc. on August 27, 2010 in Kansas City, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 27, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kansas City, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3696 | 21 CFR 820.100(b) | Documentation |