FDA inspection

Shenzhen OSTO Technology Company Limited: FDA inspection ending Mar 18, 2025

FDA inspection 1264479 · Voluntary Action Indicated (VAI) · Shenzhen

Key facts

Inspection ID 1264479
Firm Shenzhen OSTO Technology Company Limited
FEI number 3011564440
Address 4, Building 2, Zhongxin Longsheng Square, No 219 Shenshan Road (Longgang Section) Unit 2104, Bailong Road; Longgangjiedao Longgang District
City Shenzhen
Country China
Fiscal year 2025
Inspection end date Mar 18, 2025
Classification Voluntary Action Indicated (VAI)
Project area Compliance: 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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