FDA inspection

Denka Co. Ltd.: FDA inspection ending Jul 6, 2017

FDA inspection 1022352 · No Action Indicated (NAI) · Gosen

Key facts

Inspection ID 1022352
Firm Denka Co. Ltd.
FEI number 3003871639
Address Kagamida 1359-1, Kigoshi
City Gosen
Country Japan
Fiscal year 2017
Inspection end date Jul 6, 2017
Classification No Action Indicated (NAI)
Project area Compliance: 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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