FDA inspection

Abiomed, Inc.: FDA inspection ending Mar 25, 2016

FDA inspection 964416 · No Action Indicated (NAI) · Danvers, MA

Key facts

Inspection ID 964416
Firm Abiomed, Inc.
FEI number 1220648
Address 22 Cherry Hill Dr
City Danvers
State MA
ZIP 01923
Country United States
Fiscal year 2016
Inspection end date Mar 25, 2016
Classification No Action Indicated (NAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes Establishment inspection report (EIR) exists
  • 10–99 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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