Form 483

CNMC Company, Inc. Form 483, 2018-03-09

FDA issued a Form 483 to CNMC Company, Inc. on 2018-03-09 with 14 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health14 observations

CNMC Company, Inc. · Nashville, United States · Issued March 9, 2018

Overview

  • 14 public-safe observations are available for this inspection.
  • 7 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.

9 Mar 2018
21 CFR 820.100(b)

Documentation

Cited by Bonnie E Conley

9 Mar 2018
21 CFR 820.100(b)

Documentation

Cited by Bonnie E Conley

9 Mar 2018
21 CFR 820.120

Lack of or inadequate procedures for labeling

Cited by Bonnie E Conley

9 Mar 2018
21 CFR 820.120

Lack of or inadequate procedures for labeling

Cited by Bonnie E Conley

9 Mar 2018
21 CFR 820.184

DHR content

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 820.100(b)Cited across public-safe Form 483 observations2x
21 CFR 820.120Cited across public-safe Form 483 observations2x
21 CFR 820.184Cited across public-safe Form 483 observations2x
21 CFR 820.200(b)Cited across public-safe Form 483 observations2x
21 CFR 820.200(d)Cited across public-safe Form 483 observations2x
21 CFR 820.30(g)Cited across public-safe Form 483 observations2x
21 CFR 820.90(b)(2)Cited across public-safe Form 483 observations2x

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 14 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