FDA inspection

Slow Wave, Inc.: FDA inspection ending May 3, 2023

FDA inspection 1206499 · Voluntary Action Indicated (VAI) · Marble Falls, TX

Key facts

Inspection ID 1206499
Firm Slow Wave, Inc.
FEI number 3017520337
Address 617 N Us Highway 281
City Marble Falls
State TX
ZIP 78654-5141
Fiscal year 2023
Inspection end date May 3, 2023
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Medical Devices
Product type Devices

At a glance

  • None 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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