FDA-Inspected Site

Concord, Inc. dba Carlton's Dunwoody Pharmacy

2 FDA inspections are on record for Concord, Inc. dba Carlton's Dunwoody Pharmacy in Dunwoody, United States.

483· Form 483 issued

Dunwoody, United States · Last updated July 10, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2019-04-12.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
8 Apr 2019 – 12 Apr 2019Human Drugs483View 483 →
5 Jan 2016 – 13 Jan 2016Human Drugs483View 483 →

Observations on record

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

12 Apr 2019
FDCA 501(a)(2)(A)

Highly potent drugs, prevention of cross-contamination

Cited by Veronica Fuentes, Tamara J Henderson

13 Jan 2016
21 CFR 211.160(b)(4)

Calibration - at intervals, written program, remedial action

Cited by Rachael L Cook, Tamara J Henderson

13 Jan 2016
21 CFR 211.165(a)

Testing and release for distribution

Cited by Rachael L Cook, Tamara J Henderson

13 Jan 2016
21 CFR 211.166(a)

Lack of written stability program

Cited by Rachael L Cook, Tamara J Henderson

13 Jan 2016
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Rachael L Cook, Tamara J Henderson

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 211.160(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 211.165(a)Cited across public-safe Form 483 observations2x
21 CFR 211.166(a)Cited across public-safe Form 483 observations2x
21 CFR 211.188Cited across public-safe Form 483 observations2x
21 CFR 211.22(c)Cited across public-safe Form 483 observations2x
FDCA 501(a)(2)(A)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Concord, Inc. dba Carlton's Dunwoody Pharmacy'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