Form 483

CNMC Company, Inc. Form 483, 2014-02-04

FDA issued a Form 483 to CNMC Company, Inc. on 2014-02-04 with 5 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health5 observations

CNMC Company, Inc. · Nashville, United States · Issued February 4, 2014

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

4 Feb 2014
21 CFR 820.30(j)

Design history file

Cited by Bonnie E Conley

4 Feb 2014
21 CFR 820.72(a)

Calibration, Inspection, etc. Procedures Lack of or Inadequ

Cited by Bonnie E Conley

4 Feb 2014
21 CFR 820.80(e)

Documentation

Cited by Bonnie E Conley

4 Feb 2014
21 CFR 820.120(d)

Records, DHR {see also 820.184(e)}

Cited by Bonnie E Conley

4 Feb 2014
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Bonnie E Conley

Inspected site

CCCNMC Company, Inc.Nashville, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.120(d)Cited across public-safe Form 483 observations1x
21 CFR 820.181Cited across public-safe Form 483 observations1x
21 CFR 820.30(j)Cited across public-safe Form 483 observations1x
21 CFR 820.72(a)Cited across public-safe Form 483 observations1x
21 CFR 820.80(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.

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