FDA inspection

Hanmi Pharma Co., Ltd: FDA inspection ending Feb 1, 2018

FDA inspection 1044743 · Voluntary Action Indicated (VAI) · Pyeongtaek

Key facts

Inspection ID 1044743
Firm Hanmi Pharma Co., Ltd
FEI number 3009350213
Address 114 Chupalsandan-Ro, Paengseong-Eup
City Pyeongtaek
Country Korea (the Republic of)
Fiscal year 2018
Inspection end date Feb 1, 2018
Classification Voluntary Action Indicated (VAI)
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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