FDA-Inspected Site

Woodbine Products Company Inc.

8 FDA inspections are on record for Woodbine Products Company Inc. in Medina, United States.

483· Form 483 issued

Medina, United States · Last updated August 15, 2026

Overview

  • 8 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-02-13.

At a glance

Inspections

8

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
9 Feb 2026 – 13 Feb 2026Human DrugsWLView 483 →
29 Aug 2022 – 1 Sep 2022Human Drugs483On file
22 Aug 2016 – 6 Sep 2016Human Drugs483View 483 →
20 Oct 2011Not recordedClean
16 Dec 2009Not recordedClean
20 Mar 2007Not recordedClean
12 May 2005Not recordedClean
19 Sep 2002Not recordedClean

Observations on record

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

13 Feb 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Supreet K Sran

13 Feb 2026
21 CFR 211.165(a)

Testing and release for distribution

Cited by Supreet K Sran

13 Feb 2026
21 CFR 211.166(a)(3)

Valid stability test methods

Cited by Supreet K Sran

13 Feb 2026
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Supreet K Sran

13 Feb 2026
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Supreet K Sran

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 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited 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
21 CFR 211.84(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Woodbine Products Company Inc.'s 3 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