Atlas

FDA-Inspected Site

Spectranetics Corporation

4 FDA inspections are on record for Spectranetics Corporation in Fremont, United States.

Clean· No action indicated

Fremont, United States · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 0 inspections produced a Form 483.
  • The most recent recorded inspection date is 2020-09-17.

At a glance

Inspections

4

Form 483s

0

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Sep 2020 – 17 Sep 2020Medical Devices & Rad HealthClean
11 Feb 2019 – 14 Feb 2019Medical Devices & Rad HealthClean
10 Jan 2017 – 13 Jan 2017Medical Devices & Rad HealthClean
8 Dec 2015 – 9 Dec 2015Medical Devices & Rad HealthClean

Investigators

FDA investigators tied to this site in the record.

Maida Henesian3 insp.
Sneha S Patel1 insp.
Lance A Finnical1 insp.
Adam S Freeman1 insp.

Full site report

Get the verbatim findings behind Spectranetics Corporation's inspection record

The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat