FDA-Inspected Site

Universal Packaging Systems, Inc.

5 FDA inspections are on record for Universal Packaging Systems, Inc. in Batavia, United States.

Clean· No action indicated

Batavia, 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 2025-05-23.

At a glance

Inspections

5

Form 483s

2

EIRs

3

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
20 May 2025 – 23 May 2025Human DrugsClean
25 Feb 2019 – 5 Mar 2019Medical Devices & Rad Health483View 483 →
17 Dec 2013 – 19 Dec 2013Human DrugsClean
21 Oct 2011Not recorded483On file
4 May 2010Not recordedClean

Observations on record

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

5 Mar 2019
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Lauren N Howard, Teresa K Kastner

5 Mar 2019
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Lauren N Howard, Teresa K Kastner

5 Mar 2019
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Lauren N Howard, Teresa K Kastner

5 Mar 2019
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Lauren N Howard, Teresa K Kastner

5 Mar 2019
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Lauren N Howard, Teresa K Kastner

Investigators

FDA investigators tied to this site in the record.

WenNing Chan1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations6x
21 CFR 820.70(g)(1)Cited across public-safe Form 483 observations6x
21 CFR 820.72(b)Cited across public-safe Form 483 observations6x
21 CFR 820.75(a)Cited across public-safe Form 483 observations6x
21 CFR 820.90(a)Cited across public-safe Form 483 observations6x
21 CFR 211.113(a)Cited across public-safe Form 483 observations3x
21 CFR 211.198(b)Cited across public-safe Form 483 observations3x
21 CFR 211.22(d)Cited across public-safe Form 483 observations3x
21 CFR 820.100(a)Cited across public-safe Form 483 observations3x
21 CFR 820.50Cited across public-safe Form 483 observations3x
21 CFR 820.70(b)Cited across public-safe Form 483 observations3x

Full site report

Get the verbatim findings behind Universal Packaging Systems, Inc.'s 2 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