FDA inspection

Okamoto Rubber Products Co., Ltd.: FDA inspection ending Dec 22, 2016

FDA inspection 996125 · Voluntary Action Indicated (VAI) · Khlong Luang

Key facts

Inspection ID 996125
Firm Okamoto Rubber Products Co., Ltd.
FEI number 3002806673
Address 60/50, 60/51 Moo 19 Navanakorn Industrial Estate Zone 2 Paholyothin Road
City Khlong Luang
Country Thailand
Fiscal year 2017
Inspection end date Dec 22, 2016
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: Devices
Product type Devices

At a glance

  • 1–9 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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