Clinical Outsourcing

FDA Inspections

FDA Inspected Centeral and Eastern European Regions

Russia Central Europe

FDA: Inspections and findings

 

NAI

No Action Indicated

No objectionable conditions or practices were found during the inspection

VAI

Voluntary Action Indicated

Objectionable conditions were found but the problems do not justify further regulatory action. Any corrective action is left to the investigator to take voluntarily.

OAI

Official Action Indicated

Objectionable conditions were found and regulatory and/or administrative sanctions by FDA are indicated.

Russia: competitive advantages

FDA inspections Central and Eastern Europe

ICH GCP Compliance in Russia: NAI

The U.S. Food and Drug Administration found no evidence of poor GCP compliance during inspections in Russia or other emerging clinical research sites.

 

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