FDA-Inspected Site

Charles River Laboratories, Inc.

8 FDA inspections are on record for Charles River Laboratories, Inc. in Wilmington, United States.

483· Form 483 issued

Wilmington, United States · Last updated July 9, 2026

Overview

  • 8 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-09-09.

At a glance

Inspections

8

Form 483s

4

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Sep 2025 – 9 Sep 2025Human Drugs483View 483 →
28 Apr 2025 – 2 May 2025BiologicsClean
3 Feb 2020 – 11 Feb 2020Human Drugs483View 483 →
12 Jun 2017 – 21 Jun 2017Human Drugs483View 483 →
29 May 2014 – 12 Jun 2014Human Drugs483On file
20 Jul 2007Not recordedClean
15 Jun 2005Not recordedClean
12 Aug 2003Not recordedClean

Observations on record

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

9 Sep 2025
21 CFR 211.192

Written record of investigation incomplete

Cited by Erik W Koester

11 Feb 2020
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Erik W Koester

11 Feb 2020
21 CFR 211.46(b)

Equipment for Environmental Control

Cited by Erik W Koester

11 Feb 2020
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Erik W Koester

21 Jun 2017
21 CFR 211.160(a)

Lab controls established, including changes

Cited by Sean R Marcsisin

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 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.46(b)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Charles River Laboratories, Inc.'s 4 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