FDA inspection

Amphastar Nanjing Pharmaceuticals Inc: FDA inspection ending Oct 11, 2019

FDA inspection 1107981 · Voluntary Action Indicated (VAI) · Nanjing

Key facts

Inspection ID 1107981
Firm Amphastar Nanjing Pharmaceuticals Inc
FEI number 3009805706
Address No 5 Xinghe Road
City Nanjing
Country China
Fiscal year 2020
Inspection end date Oct 11, 2019
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type Drugs

At a glance

  • None 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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