Atlas

FDA-Inspected Site

Consolidated Research, Inc.

3 FDA inspections are on record for Consolidated Research, Inc. in Euclid, United States.

483· Form 483 issued

Euclid, United States · Last updated July 10, 2026

Overview

  • 3 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-03-25.

At a glance

Inspections

3

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Mar 2026 – 25 Mar 2026Medical Devices & Rad Health483View 483 →
7 Aug 2018 – 9 Aug 2018Medical Devices & Rad HealthClean
4 Feb 2013 – 7 Feb 2013Medical Devices & Rad HealthClean

Observations on record

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

25 Mar 2026
21 CFR 830.310(b)

GUDID Information required for unique device identification.

Cited by Laureen M Geniusz, Rosanna M Goodrich

25 Mar 2026
ISO 13485:2016 Clause 4.1.2

Risk-based approach not applied to QMS processes

Cited by Laureen M Geniusz, Rosanna M Goodrich

25 Mar 2026
ISO 13485:2016 Clause 4.2.1

Quality management system documentation not adequate

Cited by Laureen M Geniusz, Rosanna M Goodrich

25 Mar 2026
ISO 13485:2016 Clause 7.1

Records of risk management activities in product realization not maintained

Cited by Laureen M Geniusz, Rosanna M Goodrich

25 Mar 2026
ISO 13485:2016 Clause 7.4.1

Records of supplier (re)evaluation, selection, and monitoring not maintained

Cited by Laureen M Geniusz, Rosanna M Goodrich

Investigators

FDA investigators tied to this site in the record.

Laureen M Geniusz1 insp.
Rosanna M Goodrich1 insp.
Javonica F Penn1 insp.
Michael K Larson1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 830.310(b)Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 4.1.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 4.2.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.4.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.3.4Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.5.2Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Consolidated Research, Inc.'s 1 Form 483

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