Atlas

Form 483

DeJarnette Research Systems, Inc. Form 483, 2010-11-03

FDA issued a Form 483 to DeJarnette Research Systems, Inc. on 2010-11-03 with 2 public-safe observations.

483· Form 483 issued2 observations

DeJarnette Research Systems, Inc. · Towson, United States · Issued November 3, 2010

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

3 Nov 2010
21 CFR 820.100(b)

Documentation

Cited by Cynthia A Harris

3 Nov 2010
21 CFR 820.198(e)

Records of complaint investigation

Cited by Cynthia A Harris

Inspected site

DRDeJarnette Research Systems, Inc.Towson, United States

Inspection team

CACynthia A Harris

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.198(e)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 2 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