FDA Inspected Centeral and Eastern European Regions
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
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.