FDA-Inspected Site

Bajaj Medical, LLC

4 FDA inspections are on record for Bajaj Medical, LLC in Chicago, United States.

483· Form 483 issued

Chicago, United States · Last updated August 15, 2026

Overview

  • 4 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-08-25.

At a glance

Inspections

4

Form 483s

4

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
21 Aug 2025 – 25 Aug 2025Human Drugs483View 483 →
2 Dec 2024 – 4 Dec 2024Human Drugs483View 483 →
24 Sep 2019 – 1 Oct 2019Human Drugs483View 483 →
5 Oct 2015 – 16 Oct 2015Human Drugs483View 483 →

Observations on record

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

25 Aug 2025
21 CFR 211.84(b)

Representative Samples Criteria

Cited by Tyler M Peterson

4 Dec 2024
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Jennifer C Adams

1 Oct 2019
21 CFR 211.180(e)(2)

Items to cover on annual reviews

Cited by Vioela J Caze

16 Oct 2015
21 CFR 211.166(a)

Written program not followed

Cited by Brian D Nicholson

16 Oct 2015
21 CFR 211.166(a)

Written program not followed

Cited by Brian D Nicholson

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 211.166(a)Cited across public-safe Form 483 observations2x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.198(a)Cited across public-safe Form 483 observations2x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.84(b)Cited across public-safe Form 483 observations1x
21 CFR 314.80(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Bajaj Medical, LLC's 4 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