FDA inspection

Karex Industries Sdn Bhd: FDA inspection ending May 11, 2006

FDA inspection 428285 · Official Action Indicated (OAI) · Pontian

Key facts

Inspection ID 428285
Firm Karex Industries Sdn Bhd
FEI number 1000535235
Address Ptd 7906 & 7907, Taman Pontian Jaya, Batu 34
City Pontian
Fiscal year 2006
Inspection end date May 11, 2006
Classification Official Action Indicated (OAI)
Project area Compliance: Med 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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