FDA-Inspected Site

Frontida Biopharm, LLC

6 FDA inspections are on record for Frontida Biopharm, LLC in Aurora, United States.

483· Form 483 issued

Aurora, United States · Last updated July 10, 2026

Overview

  • 6 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2025-10-24.

At a glance

Inspections

6

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
20 Oct 2025 – 24 Oct 2025Human Drugs483View 483 →
24 Feb 2021 – 26 Feb 2021Human DrugsClean
11 Feb 2016 – 18 Feb 2016Human DrugsClean
13 Feb 2013 – 26 Feb 2013Human DrugsClean
16 Aug 2011Not recordedClean
5 Jan 2010Not recordedClean

Observations on record

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

24 Oct 2025
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Angela C Welker

24 Oct 2025
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Angela C Welker

24 Oct 2025
21 CFR 211.22(a)

Lack of quality control unit

Cited by Angela C Welker

24 Oct 2025
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Angela C Welker

Investigators

FDA investigators tied to this site in the record.

Bruce H Mccullough1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Frontida Biopharm, LLC's 1 Form 483

Source PDFs 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