FDA Inspection
CGR Products MN, LLC.CGR Products MN, LLC. – FDA Inspection, Mar 12, 2026
Record Details
This FDA Inspection record concerns CGR Products MN, LLC., with an inspection on March 12, 2026, issued by the Minneapolis District Office, covering medical devices & rad health.
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ID · 5d3fdca6-2391-48d8-8b81-73742d8966e2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1308058
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
3- ISO 13485:2016 Clause 7.5.1Production controls not adequate
- ISO 13485:2016 Clause 8.3.1Records of nonconforming product and actions taken not maintained
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of CGR Products MN, LLC.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 15, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CGR Products MN, LLC.
- FDA Inspection 1165415 - 2022-03-02
- FDA Inspection 1032347 - 2017-11-15
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