FDA inspection

Nippon Fine Chemical Co., Ltd.: FDA inspection ending Dec 17, 2015

FDA inspection 951391 · Official Action Indicated (OAI) · Takasago

Key facts

Inspection ID 951391
Firm Nippon Fine Chemical Co., Ltd.
FEI number 3001722961
Address 5 Chome 1-1, Umei
City Takasago
Country Japan
Fiscal year 2016
Inspection end date Dec 17, 2015
Classification Official Action Indicated (OAI)
Project area Drug Quality Assurance
Product type Drugs
Warning letter 501158

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • Yes 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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