Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-14.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Nov 2025 – 14 Nov 2025 | Human Drugs | 483 | View 483 → |
| 12 Apr 2022 – 14 Apr 2022 | Human Drugs | Clean | |
| 4 Aug 2021 – 12 Aug 2021 | Human Drugs | 483 | View 483 → |
| 6 Sep 2017 | Human Drugs | Clean | |
| 15 Jun 2015 – 16 Jun 2015 | Human Drugs | Clean | |
| 24 Aug 2011 | Not recorded | Clean | |
| 5 Oct 2010 | Not recorded | 483 | View 483 → |
| 22 Mar 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Nov 2025
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by David A Oluwo, Daniel T Lee
Investigators
FDA investigators tied to this site in the record.
Anita R Michael4 insp.
David A Oluwo1 insp.
Daniel T Lee1 insp.
Rachael O Oyewole1 insp.
Stephanie C Mangigian1 insp.
Jason M Sluzynski1 insp.
Cynthia White1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.44 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.82(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Marlex Pharmaceuticals, 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