FDA inspection

SM Biomed Sdn Bhd: FDA inspection ending Mar 11, 2016

FDA inspection 972744 · Voluntary Action Indicated (VAI) · Sungai Petani

Key facts

Inspection ID 972744
Firm SM Biomed Sdn Bhd
FEI number 3005983287
Address Lot 90, Sungai Petani
City Sungai Petani
Country Malaysia
Fiscal year 2016
Inspection end date Mar 11, 2016
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type Drugs

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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