FDA Inspection 563965 — Lake Region Manufacturing, Inc
The FDA completed an inspection of Lake Region Manufacturing, Inc on Feb 17, 2009 in Chaska, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 17, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Chaska, MN (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |