Atlas

FDA-Inspected Site

Concept Laboratories, Inc.

10 FDA inspections are on record for Concept Laboratories, Inc. in Chicago, United States.

483· Form 483 issued

Chicago, United States · Last updated July 10, 2026

Overview

  • 10 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2019-11-15.

At a glance

Inspections

10

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
6 Nov 2019 – 15 Nov 2019Human Drugs483View 483 →
11 Jan 2016 – 15 Jan 2016Human DrugsClean
15 Apr 2013 – 19 Apr 2013Human Drugs483View 483 →
8 Apr 2011Not recorded483View 483 →
17 Feb 2010Not recorded483On file
18 Jan 2008Not recordedWLOn file
30 Sep 2005Not recordedClean
29 Sep 2004Not recordedClean
22 Jan 2003Not recordedClean
23 Aug 2001Not recordedClean

Observations on record

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

15 Nov 2019
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Vioela J Caze

15 Nov 2019
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Vioela J Caze

15 Nov 2019
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Vioela J Caze

15 Nov 2019
21 CFR 211.42(a)

Buildings of Suitable Size, Construction, Location

Cited by Vioela J Caze

15 Nov 2019
21 CFR 211.63

Equipment Design, Size and Location

Cited by Vioela J Caze

Investigators

FDA investigators tied to this site in the record.

Debra I Love3 insp.
Carrie-Ann Plucinski2 insp.
Vioela J Caze1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(a)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Concept Laboratories, Inc.'s 5 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