FDA-Inspected Site

Corindus Inc

2 FDA inspections are on record for Corindus Inc in Waltham, United States.

483· Form 483 issued

Waltham, United States · Last updated August 15, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2021-07-27.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
21 Jul 2021 – 27 Jul 2021Medical Devices & Rad Health483View 483 →
27 Sep 2016 – 4 Oct 2016Medical Devices & Rad Health483View 483 →

Observations on record

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

27 Jul 2021
21 CFR 820.100(b)

Documentation

Cited by Sara M Onyango, David C Sullivan

27 Jul 2021
21 CFR 820.100(b)

Documentation

Cited by Sara M Onyango, David C Sullivan

4 Oct 2016
21 CFR 803.50(a)(2)

Report of Malfunction

Cited by Nabil Nakhoul

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 820.100(b)Cited across public-safe Form 483 observations2x
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Corindus Inc's 2 Form 483s

Source PDFs, verbatim observations, 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