FDA-Inspected Site

Aurolife Pharma LLC

3 FDA inspections are on record for Aurolife Pharma LLC in Durham, United States.

483· Form 483 issued

Durham, United States · Last updated July 10, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-04-10.

At a glance

Inspections

3

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Mar 2025 – 10 Apr 2025Human Drugs483On file
22 Aug 2022 – 26 Aug 2022Human Drugs483View 483 →
28 May 2019 – 31 May 2019Human DrugsClean

Observations on record

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

26 Aug 2022
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Tyler R Courtney, Shelby N Turner

26 Aug 2022
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Tyler R Courtney, Shelby N Turner

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 820.100(a)Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind Aurolife Pharma LLC's 2 Form 483s

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