FDA Inspection 1308058 — CGR Products MN, LLC.
The FDA completed an inspection of CGR Products MN, LLC. on March 12, 2026 in Inver Grove Heights, MN. 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
- March 12, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Inver Grove Heights, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23156 | ISO 13485:2016 Clause 7.5.1 | Production controls not adequate |
| 23239 | ISO 13485:2016 Clause 8.3.1 | Records of nonconforming product and actions taken not maintained |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |