FDA-Inspected Site

WES Pharma Inc.

8 FDA inspections are on record for WES Pharma Inc. in Westminster, United States.

483· Form 483 issued

Westminster, United States · Last updated July 10, 2026

Overview

  • 8 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-11-20.

At a glance

Inspections

8

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
12 Nov 2025 – 20 Nov 2025Human Drugs483View 483 →
17 Nov 2023 – 21 Nov 2023Human Drugs483View 483 →
14 Feb 2022 – 18 Feb 2022Human Drugs483View 483 →
26 Apr 2021 – 28 Apr 2021Human DrugsClean
2 Dec 2019 – 20 Dec 2019Human Drugs483View 483 →
15 Apr 2019 – 19 Apr 2019Human DrugsClean
3 Dec 2018 – 13 Dec 2018Human Drugs483View 483 →
26 Oct 2015 – 6 Nov 2015Human Drugs483View 483 →

Observations on record

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

20 Nov 2025
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Pushpa S Jayasekara

20 Nov 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Pushpa S Jayasekara

20 Nov 2025
21 CFR 211.194(a)(8)

Second person sign off

Cited by Pushpa S Jayasekara

20 Nov 2025
21 CFR 211.22(a)

Authority lacking to review records, investigate errors

Cited by Pushpa S Jayasekara

20 Nov 2025
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Pushpa S Jayasekara

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 211.67(b)Cited across public-safe Form 483 observations6x
21 CFR 211.192Cited across public-safe Form 483 observations5x
21 CFR 211.22(d)Cited across public-safe Form 483 observations5x
21 CFR 211.63Cited across public-safe Form 483 observations3x
21 CFR 211.100(b)Cited across public-safe Form 483 observations2x
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.166(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.188Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.68(a)Cited across public-safe Form 483 observations2x
21 CFR 211.68(b)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind WES Pharma 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