FDA inspection

Nippon Shinyaku Co., Ltd.: FDA inspection ending Nov 9, 2019

FDA inspection 1109241 · Voluntary Action Indicated (VAI) · Kyoto

Key facts

Inspection ID 1109241
Firm Nippon Shinyaku Co., Ltd.
FEI number 3002583204
Address 14, Kisshoinnishinoshomonguchicho, Minami-Ku, Kisshoinnishinoshomonguchi-Cho; Minami
City Kyoto
Fiscal year 2020
Inspection end date Nov 9, 2019
Classification Voluntary Action Indicated (VAI)
Project area New Drug Evaluation
Product type Drugs

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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