FDA-Inspected Site

Metrex Research, LLC.

10 FDA inspections are on record for Metrex Research, LLC. in Romulus, United States.

483· Form 483 issued

Romulus, United States · Last updated July 9, 2026

Overview

  • 10 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-01.

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
27 Apr 2026 – 1 May 2026Human Drugs483On file
3 May 2022 – 20 May 2022Human Drugs483View 483 →
17 Dec 2018 – 19 Dec 2018Medical Devices & Rad HealthClean
3 May 2017 – 5 May 2017Medical Devices & Rad Health483On file
13 Jul 2015 – 15 Jul 2015Medical Devices & Rad Health483On file
3 Jun 2014 – 5 Jun 2014Medical Devices & Rad HealthClean
28 Feb 2012Not recorded483View 483 →
5 Mar 2010Not recordedClean
14 Jun 2001Not recordedClean
25 Feb 2000Not recordedClean

Observations on record

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

20 May 2022
21 CFR 211.122(d)

Label storage access limited to authorized personnel

Cited by Alan M Barker, Jacob G Lutz, Brent M Dehaan

20 May 2022
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Alan M Barker, Jacob G Lutz, Brent M Dehaan

20 May 2022
21 CFR 211.165(b)

Microbiological testing

Cited by Alan M Barker, Jacob G Lutz, Brent M Dehaan

20 May 2022
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Alan M Barker, Jacob G Lutz, Brent M Dehaan

20 May 2022
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Alan M Barker, Jacob G Lutz, Brent M Dehaan

Investigators

FDA investigators tied to this site in the record.

MDSAP harperd3 insp.
Brent M Dehaan1 insp.
MSDAP GonzlezK1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.122(d)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 806.10(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Metrex Research, LLC.'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