FDA-Inspected Site

Biostructures, LLC

5 FDA inspections are on record for Biostructures, LLC in Newport Beach, United States.

Clean· No action indicated

Newport Beach, United States · Last updated July 10, 2026

Overview

  • 5 FDA inspections are on record.
  • 0 inspections produced a Form 483.
  • The most recent recorded inspection date is 2017-09-07.

At a glance

Inspections

5

Form 483s

0

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
6 Sep 2017 – 7 Sep 2017Medical Devices & Rad HealthClean
12 Sep 2016 – 14 Sep 2016Medical Devices & Rad HealthClean
18 Feb 2015Medical Devices & Rad HealthClean
18 Oct 2012Not recordedClean
17 May 2010Not recordedClean

Investigators

FDA investigators tied to this site in the record.

MDSAP harperd2 insp.

Full site report

Get the verbatim findings behind Biostructures, LLC'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