FDA-Inspected Site

Gateway Analytical, LLC

5 FDA inspections are on record for Gateway Analytical, LLC in Gibsonia, United States.

483· Form 483 issued

Gibsonia, United States · Last updated August 15, 2026

Overview

  • 5 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-20.

At a glance

Inspections

5

Form 483s

2

EIRs

3

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
18 Mar 2026 – 20 Mar 2026Human Drugs483View 483 →
13 Sep 2022 – 16 Sep 2022Human Drugs483On file
13 Apr 2021 – 14 Apr 2021Human DrugsClean
15 Jan 2015Human DrugsClean
5 Nov 2012Not recordedClean

Observations on record

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

20 Mar 2026
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Kara J Wright

Investigators

FDA investigators tied to this site in the record.

Mary R Kirker1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Gateway Analytical, 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