FDA inspection

Omnimate Enterprise Co., Ltd.: FDA inspection ending Sep 12, 2019

FDA inspection 1105896 · Voluntary Action Indicated (VAI) · Yilan County

Key facts

Inspection ID 1105896
Firm Omnimate Enterprise Co., Ltd.
FEI number 3009771213
Address Ln. 126, No. 8 Ligong 1st Rd., Sec. 2; Wujie Township
City Yilan County
Country Taiwan
Fiscal year 2019
Inspection end date Sep 12, 2019
Classification Voluntary Action Indicated (VAI)
Project area Compliance: 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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