Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-04.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Jun 2026 – 4 Jun 2026 | Human Drugs | Clean | |
| 12 Dec 2017 – 15 Dec 2017 | Human Drugs | 483 | View 483 → |
| 10 Aug 2015 – 13 Aug 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Aug 2015
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Rachael L Cook, Tamara J Henderson, Constance Y Fears
13 Aug 2015
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Rachael L Cook, Tamara J Henderson, Constance Y Fears
13 Aug 2015
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Rachael L Cook, Tamara J Henderson, Constance Y Fears
Investigators
FDA investigators tied to this site in the record.
Tomika L Crafter1 insp.
Gideon N Esuzor1 insp.
Rachael L Cook1 insp.
Tamara J Henderson1 insp.
Constance Y Fears1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Direct Rx's 2 Form 483s
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