FDA-Inspected Site

Surmodics Inc

5 FDA inspections are on record for Surmodics Inc in Eden Prairie, United States.

Clean· No action indicated

Eden Prairie, United States · Last updated July 11, 2026

Overview

  • 5 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-05-29.

At a glance

Inspections

5

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
27 May 2026 – 29 May 2026Medical Devices & Rad HealthClean
2 Nov 2021 – 4 Nov 2021Medical Devices & Rad Health483View 483 →
7 Oct 2021 – 19 Oct 2021Medical Devices & Rad HealthClean
7 Jan 2015 – 14 Jan 2015Medical Devices & Rad HealthClean
1 Nov 2010Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

4 Nov 2021
21 CFR 812.140(b)(2)

Sponsor device disposition records inadequate

Cited by Denise L Burosh

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 812.140(b)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Surmodics Inc's 1 Form 483

Source PDFs and recurring CFR citations, 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