Form 483

Martin Memorial Health Systems IEB Form 483, 2011-06-24

FDA issued a Form 483 to Martin Memorial Health Systems IEB on 2011-06-24 with 3 public-safe observations.

483· Form 483 issued3 observations

Martin Memorial Health Systems IEB · Stuart, United States · Issued June 24, 2011

Overview

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

Inspectional observations

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

24 Jun 2011
21 CFR 50.25(a)(5)

Confidentiality, FDA inspection of records

Cited by Paul A Licata, Lisa K Capron

24 Jun 2011
21 CFR 56.108(c)

Members present for review

Cited by Paul A Licata, Lisa K Capron

24 Jun 2011
21 CFR 56.115(a)(2)

Minutes of IRB meetings

Cited by Paul A Licata, Lisa K Capron

Inspected site

MMMartin Memorial Health Systems IEBStuart, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 50.25(a)(5)Cited across public-safe Form 483 observations1x
21 CFR 56.108(c)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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