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FDA inspection

Helsinn Birex Pharmaceuticals Ltd.: FDA inspection ending Jul 11, 2008

FDA inspection 527002 · No Action Indicated (NAI) · Mulhuddart

Key facts

Inspection ID 527002
Firm Helsinn Birex Pharmaceuticals Ltd.
FEI number 3003724414
Address Damastown Industrial Estate
City Mulhuddart
Fiscal year 2008
Inspection end date Jul 11, 2008
Classification No Action Indicated (NAI)
Project area Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation
Product type Drugs

At a glance

  • None Citations
  • None 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.

Other inspections at this establishment

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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