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Form 483

Deseret Laboratories, Inc. Form 483, 2011-09-02

FDA issued a Form 483 to Deseret Laboratories, Inc. on 2011-09-02 with 5 public-safe observations.

483· Form 483 issued5 observations

Deseret Laboratories, Inc. · Saint George, United States · Issued September 2, 2011

Overview

  • 5 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

2 Sep 2011
21 CFR 211.166(a)

Written program not followed

Cited by Nathan R Moon

2 Sep 2011
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Nathan R Moon

2 Sep 2011
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Nathan R Moon

2 Sep 2011
21 CFR 211.192

Quality control unit review of records

Cited by Nathan R Moon

2 Sep 2011
21 CFR 211.198(b)(3)

Reason for Not Conducting Complaint Investigation

Cited by Nathan R Moon

Inspected site

DLDeseret Laboratories, Inc.Saint George, United States

Inspection team

NRNathan R Moon

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(3)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 5 observations

The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere