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.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Apr 2019 – 12 Apr 2019 | Human Drugs | 483 | View 483 → |
| 5 Jan 2016 – 13 Jan 2016 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Highly potent drugs, prevention of cross-contamination
Cited by Veronica Fuentes, Tamara J Henderson
Calibration - at intervals, written program, remedial action
Cited by Rachael L Cook, Tamara J Henderson
Testing and release for distribution
Cited by Rachael L Cook, Tamara J Henderson
Lack of written stability program
Cited by Rachael L Cook, Tamara J Henderson
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.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 2x |
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 1x |
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