FDA inspection

TransMedics, Inc.: FDA inspection ending Apr 26, 2017

FDA inspection 1013092 · Voluntary Action Indicated (VAI) · Andover, MA

Key facts

Inspection ID 1013092
Firm TransMedics, Inc.
FEI number 3003152463
Address 200 Minuteman Rd Ste 302
City Andover
State MA
ZIP 01810
Country United States
Fiscal year 2017
Inspection end date Apr 26, 2017
Classification Voluntary Action Indicated (VAI)
Project area Bioresearch Monitoring
Product type Devices

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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