Atlas

FDA-Inspected Site

Navajo Manufacturing Company

9 FDA inspections are on record for Navajo Manufacturing Company in Denver, United States.

483· Form 483 issued

Denver, United States · Last updated August 15, 2026

Overview

  • 9 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2014-12-05.

At a glance

Inspections

9

Form 483s

7

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 Dec 2014 – 5 Dec 2014Medical Devices & Rad Health483View 483 →
11 Aug 2014 – 22 Aug 2014Human Drugs483View 483 →
27 Jun 2013 – 9 Jul 2013Human Drugs483View 483 →
11 Jun 2012Not recorded483On file
28 Jan 2011Not recorded483View 483 →
11 Mar 2010Not recorded483On file
29 Dec 2009Not recorded483View 483 →
30 Apr 2003Not recordedClean
10 Jul 2002Not recordedClean

Observations on record

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

5 Dec 2014
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Thai T Duong

22 Aug 2014
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Paul Z Balcer

22 Aug 2014
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Paul Z Balcer

22 Aug 2014
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Paul Z Balcer

22 Aug 2014
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Paul Z Balcer

Investigators

FDA investigators tied to this site in the record.

Thai T Duong1 insp.
Paul Z Balcer1 insp.
Edith M Gonzalez1 insp.
Isabel Y Espinosa1 insp.
Caroline H Le1 insp.
Linda M Cherry1 insp.
Debra L Curtis1 insp.
Matthew R Dionne1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations3x
21 CFR 211.198(a)Cited across public-safe Form 483 observations3x
21 CFR 211.22(d)Cited across public-safe Form 483 observations3x
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.125(a)Cited across public-safe Form 483 observations2x
21 CFR 211.150(b)Cited across public-safe Form 483 observations2x
21 CFR 211.188Cited across public-safe Form 483 observations2x
21 CFR 211.25(a)Cited across public-safe Form 483 observations2x
21 CFR 211.67(b)Cited across public-safe Form 483 observations2x
21 CFR 211.115(b)Cited across public-safe Form 483 observations1x
21 CFR 211.134(b)Cited across public-safe Form 483 observations1x
21 CFR 211.142(a)Cited across public-safe Form 483 observations1x
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(f)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(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 211.82(a)Cited across public-safe Form 483 observations1x
21 CFR 803.17Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Navajo Manufacturing Company's 7 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