FDA inspection

DKK Dai-Ichi Shomei Co., Ltd.: FDA inspection ending Jul 20, 2018

FDA inspection 1062324 · Official Action Indicated (OAI) · Itabashi

Key facts

Inspection ID 1062324
Firm DKK Dai-Ichi Shomei Co., Ltd.
FEI number 3006437518
Address 1 Chome 32-26, Sakashita
City Itabashi
Country Japan
Fiscal year 2018
Inspection end date Jul 20, 2018
Classification Official Action Indicated (OAI)
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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