FDA Inspection
Hanuri Distribution IncHanuri Distribution Inc – FDA Inspection, Mar 26, 2026
Record Details
This FDA Inspection record concerns Hanuri Distribution Inc, with an inspection on March 26, 2026, issued by the Los Angeles District Office, covering medical devices & rad health.
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ID · 934b7717-1ac3-4270-9826-de07de6c1fef
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1309458
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
5- ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
- ISO 13485:2016 Clause 5.6.1Procedure for nonconforming product not documented
- ISO 13485:2016 Clause 5.6.1Management review procedures not documented
- ISO 13485:2016 Clause 7.3.5Records of design and development reviews not maintained
- ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hanuri Distribution Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 22, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 9, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 9, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hanuri Distribution Inc
- FDA Inspection 1147676 - 2021-07-22
- FDA Inspection 996932 - 2016-11-09
- FDA Inspection 859363 - 2013-12-09
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