FDA inspection

Topchem Pharmaceuticals Ltd: FDA inspection ending Feb 19, 2016

FDA inspection 963195 · Voluntary Action Indicated (VAI) · Sligo

Key facts

Inspection ID 963195
Firm Topchem Pharmaceuticals Ltd
FEI number 3006810418
Address Ballymote Road, Ballymote Business PARK
City Sligo
Country Ireland
Fiscal year 2016
Inspection end date Feb 19, 2016
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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