FDA inspection

Sekisui Diagnostics, LLC: FDA inspection ending Dec 10, 2019

FDA inspection 1113282 · No Action Indicated (NAI) · Burlington, MA

Key facts

Inspection ID 1113282
Firm Sekisui Diagnostics, LLC
FEI number 3008776041
Address 1 Wall St
City Burlington
State MA
ZIP 01803
Country United States
Fiscal year 2020
Inspection end date Dec 10, 2019
Classification No Action Indicated (NAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • No 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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