Atlas

Form 483

Med-Logics, Inc. Form 483, 2016-05-24

FDA issued a Form 483 to Med-Logics, Inc. on 2016-05-24 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Med-Logics, Inc. · Athens, United States · Issued May 24, 2016

Overview

  • 4 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.

24 May 2016
21 CFR 820.100(b)

Documentation

Cited by Leighton K Ngai

24 May 2016
21 CFR 820.100(b)

Documentation

Cited by Leighton K Ngai

24 May 2016
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Leighton K Ngai

24 May 2016
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Leighton K Ngai

Inspected site

MIMed-Logics, Inc.Athens, United States

Inspection team

LKLeighton K Ngai

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 820.184Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 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