FDA Inspection
ReFlow MedicalReFlow Medical – FDA Inspection, Sep 21, 2026
Record Details
This FDA Inspection record concerns ReFlow Medical, with an inspection on September 21, 2026, issued by the Los Angeles District Office, covering medical devices & rad health.
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ID · e355cbf9-1a7d-4f99-9bb9-bb03763b9c28
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1336746
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
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Other FDA inspections of ReFlow Medical
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 9, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 28, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 26, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ReFlow Medical
- FDA Inspection 1172424 - 2022-06-09
- FDA Inspection 1079508 - 2018-11-28
- FDA Inspection 916547 - 2015-02-26
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