FDA inspection

Engineered Medical Systems Malaysia SDN BHD: FDA inspection ending Aug 18, 2016

FDA inspection 983914 · No Action Indicated (NAI) · Bukit Mertajam

Key facts

Inspection ID 983914
Firm Engineered Medical Systems Malaysia SDN BHD
FEI number 3011503227
Address Penang Science Park, 1114 Jalan Perindustrian
City Bukit Mertajam
Country Malaysia
Fiscal year 2016
Inspection end date Aug 18, 2016
Classification No Action Indicated (NAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • No 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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