FDA inspection

Reflow Medical: FDA inspection ending Mar 5, 2026

FDA inspection 1305822 · Voluntary Action Indicated (VAI) · Lake Forest, CA

Key facts

Inspection ID 1305822
Firm Reflow Medical
FEI number 3027058844
Address 20532 Crescent Bay Dr Ste 102
City Lake Forest
State CA
ZIP 92630
Country United States
Fiscal year 2026
Inspection end date Mar 5, 2026
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: Devices
Product type Devices

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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