FDA inspection

SPH Sine Pharmaceutical Laboratories Co., Ltd.: FDA inspection ending Jul 31, 2015

FDA inspection 936944 · Official Action Indicated (OAI) · Shanghai

Key facts

Inspection ID 936944
Firm SPH Sine Pharmaceutical Laboratories Co., Ltd.
FEI number 3004391730
Address 905 Xin Jinqiao Road, Pudongxin
City Shanghai
Country China
Fiscal year 2015
Inspection end date Jul 31, 2015
Classification Official Action Indicated (OAI)
Project area Drug Quality Assurance
Product type Drugs

At a glance

  • 10–99 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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