FDA inspection

MaineHealth IRB #1: FDA inspection ending Feb 27, 2004

FDA inspection 315120 · Official Action Indicated (OAI) · Portland, ME

Key facts

Inspection ID 315120
Firm MaineHealth IRB #1
FEI number 3003354649
Address 509 Forest Ave Ste 350
City Portland
State ME
ZIP 04101-1521
Fiscal year 2004
Inspection end date Feb 27, 2004
Classification Official Action Indicated (OAI)
Project area Product Evaluation: Med Devices
Product type Devices

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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