FDA Inspection 883853 — Kulzer, LLC.
The FDA completed an inspection of Kulzer, LLC. on June 20, 2014 in South Bend, IN. 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
- June 20, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- South Bend, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |