Atlas

FDA-Inspected Site

RXW CGMP, LLC

3 FDA inspections are on record for RXW CGMP, LLC in Dearborn, United States.

483· Form 483 issued

Dearborn, United States · Last updated July 9, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2017-07-21.

At a glance

Inspections

3

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
27 Jun 2017 – 21 Jul 2017Foods & Cosmetics483View 483 →
28 Jun 2011Not recorded483View 483 →
2 Jul 2009Not recordedClean

Observations on record

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

21 Jul 2017
21 CFR 111.180(b)(2)

Records - receiving; components, packaging, labels, products

Cited by Kathryn A Guardiola, Martin R Vowell, Jacob A Clark, Kathryn G Brown

21 Jul 2017
21 CFR 111.180(b)(3)

Documentation - components

Cited by Kathryn A Guardiola, Martin R Vowell, Jacob A Clark, Kathryn G Brown

21 Jul 2017
21 CFR 111.210(h)(3)(ii)(B)

Components; add, verify

Cited by Kathryn A Guardiola, Martin R Vowell, Jacob A Clark, Kathryn G Brown

21 Jul 2017
21 CFR 111.210(h)(5)

Corrective action plans

Cited by Kathryn A Guardiola, Martin R Vowell, Jacob A Clark, Kathryn G Brown

21 Jul 2017
21 CFR 111.260(j)(1)

Batch record - date, each step

Cited by Kathryn A Guardiola, Martin R Vowell, Jacob A Clark, Kathryn G Brown

Investigators

FDA investigators tied to this site in the record.

Kathryn A Guardiola1 insp.
Martin R Vowell1 insp.
Jacob A Clark1 insp.
Kathryn G Brown1 insp.
Michele L Forster1 insp.
Rasha Bamieh1 insp.
Rohn R Robertson1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 111.35(b)(3)Cited across public-safe Form 483 observations2x
21 CFR 111.70(e)Cited across public-safe Form 483 observations2x
21 CFR 111.153Cited across public-safe Form 483 observations1x
21 CFR 111.155(c)Cited across public-safe Form 483 observations1x
21 CFR 111.155(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.180(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.180(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 111.210(h)(3)(ii)(B)Cited across public-safe Form 483 observations1x
21 CFR 111.210(h)(5)Cited across public-safe Form 483 observations1x
21 CFR 111.25(b)Cited across public-safe Form 483 observations1x
21 CFR 111.25(c)Cited across public-safe Form 483 observations1x
21 CFR 111.260(c)Cited across public-safe Form 483 observations1x
21 CFR 111.260(d)Cited across public-safe Form 483 observations1x
21 CFR 111.260(f)Cited across public-safe Form 483 observations1x
21 CFR 111.260(j)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.430(b)Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.70(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.70(d)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(B)Cited across public-safe Form 483 observations1x
21 CFR 111.75(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.77(a)Cited across public-safe Form 483 observations1x
21 CFR 111.87Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind RXW CGMP, LLC'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