FDA inspection

Shenzhen Biocare Bio-Medical Equipment Co., Ltd.: FDA inspection ending Jan 24, 2019

FDA inspection 1080540 · Voluntary Action Indicated (VAI) · Shenzhen

Key facts

Inspection ID 1080540
Firm Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
FEI number 3008457078
Address 1 Jinhui Road, Jinsha Commmunity, Pingshan New District
City Shenzhen
Country China
Fiscal year 2019
Inspection end date Jan 24, 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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