Atlas

FDA-Inspected Site

Integrated Biomedical Technology, Inc.

7 FDA inspections are on record for Integrated Biomedical Technology, Inc. in Elkhart, United States.

483· Form 483 issued

Elkhart, United States · Last updated July 9, 2026

Overview

  • 7 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2019-12-19.

At a glance

Inspections

7

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
17 Dec 2019 – 19 Dec 2019Medical Devices & Rad Health483View 483 →
20 Jun 2017 – 23 Jun 2017Medical Devices & Rad Health483View 483 →
13 Mar 2014 – 18 Mar 2014Medical Devices & Rad Health483On file
29 Mar 2012Not recorded483View 483 →
7 Aug 2009Not recorded483View 483 →
11 Aug 2008Not recorded483On file
23 Apr 2002Not recordedClean

Observations on record

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

19 Dec 2019
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Suyang Qin

19 Dec 2019
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Suyang Qin

19 Dec 2019
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Suyang Qin

19 Dec 2019
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Suyang Qin

19 Dec 2019
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Suyang Qin

Investigators

FDA investigators tied to this site in the record.

Suyang Qin2 insp.
Eric S Pittman2 insp.
Brian M Campbell1 insp.
Brian P Putz1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations3x
21 CFR 820.72(a)Cited across public-safe Form 483 observations3x
21 CFR 820.75(a)Cited across public-safe Form 483 observations3x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.22Cited across public-safe Form 483 observations2x
21 CFR 820.70(a)Cited across public-safe Form 483 observations2x
21 CFR 820.72(b)Cited across public-safe Form 483 observations2x
21 CFR 820.150Cited across public-safe Form 483 observations1x
21 CFR 820.184(e)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.70(c)Cited across public-safe Form 483 observations1x
21 CFR 820.80(c)Cited across public-safe Form 483 observations1x
21 CFR 820.80(e)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Integrated Biomedical Technology, Inc.'s 6 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