Form 483

MRP, LLC Form 483, 2016-04-28

FDA issued a Form 483 to MRP, LLC on 2016-04-28 with 12 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health12 observations

MRP, LLC · Nashville, United States · Issued April 28, 2016

Overview

  • 12 public-safe observations are available for this inspection.
  • 6 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

28 Apr 2016
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Bonnie E Conley, Mary A Millner, Bonnie E Pierson

28 Apr 2016
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Bonnie E Conley, Mary A Millner, Bonnie E Pierson

28 Apr 2016
21 CFR 820.100(b)

Documentation

Cited by Bonnie E Conley, Mary A Millner, Bonnie E Pierson

28 Apr 2016
21 CFR 820.100(b)

Documentation

Cited by Bonnie E Conley, Mary A Millner, Bonnie E Pierson

28 Apr 2016
21 CFR 820.70(c)

Environmental control Lack of or inadequate procedures

Cited by Bonnie E Conley, Mary A Millner, Bonnie E Pierson

Inspected site

MLMRP, LLCNashville, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.100(b)Cited across public-safe Form 483 observations2x
21 CFR 820.70(c)Cited across public-safe Form 483 observations2x
21 CFR 820.75(b)Cited across public-safe Form 483 observations2x
21 CFR 820.75(c)Cited across public-safe Form 483 observations2x
21 CFR 820.80(c)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 12 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