FDA inspection

Acuity Surgical Devices, LLC: FDA inspection ending Jan 27, 2025

FDA inspection 1259220 · Voluntary Action Indicated (VAI) · Irving, TX

Key facts

Inspection ID 1259220
Firm Acuity Surgical Devices, LLC
FEI number 3010866843
Address 8710 N Royal Ln
City Irving
State TX
ZIP 75063
Country United States
Fiscal year 2025
Inspection end date Jan 27, 2025
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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