Atlas

Form 483

Sterimed, LLC Form 483, 2017-03-20

FDA issued a Form 483 to Sterimed, LLC on 2017-03-20 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Sterimed, LLC · Cartersville, United States · Issued March 20, 2017

Overview

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

Inspectional observations

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

20 Mar 2017
21 CFR 820.100(b)

Documentation

Cited by Melanie W Pishnery

20 Mar 2017
21 CFR 820.100(b)

Documentation

Cited by Melanie W Pishnery

Inspected site

SLSterimed, LLCCartersville, United States

Inspection team

MWMelanie W Pishnery

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 observations

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