FDA inspection

St. Mary's Regional Medical Center IRB: FDA inspection ending Aug 2, 2005

FDA inspection 388419 · Voluntary Action Indicated (VAI) · Lewiston, ME

Key facts

Inspection ID 388419
Firm St. Mary's Regional Medical Center IRB
FEI number 1283750
Address 93 Campus Ave
City Lewiston
State ME
ZIP 04240-6030
Fiscal year 2005
Inspection end date Aug 2, 2005
Classification Voluntary Action Indicated (VAI)
Project area Bio-Research Monit: Human Drugs
Product type Drugs

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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