FDA-Inspected Site

Equilibrated Bio Systems

5 FDA inspections are on record for Equilibrated Bio Systems in Smithtown, United States.

Clean· No action indicated

Smithtown, United States · Last updated July 10, 2026

Overview

  • 5 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2021-11-16.

At a glance

Inspections

5

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Nov 2021Medical Devices & Rad HealthClean
2 Oct 2018Medical Devices & Rad HealthClean
23 Jul 2015Medical Devices & Rad HealthClean
14 Jan 2013Not recordedClean
2 Mar 2010Not recorded483View 483 →

Observations on record

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

2 Mar 2010
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Ronald Ifraimov

2 Mar 2010
21 CFR 820.30(a)

Design control - no procedures

Cited by Ronald Ifraimov

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 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.30(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Equilibrated Bio Systems' 1 Form 483

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