Atlas

Form 483

GE Medical Systems, LLC (dba GE Healthcare Specialty MR) Form 483, 2011-01-11

FDA issued a Form 483 to GE Medical Systems, LLC (dba GE Healthcare Specialty MR) on 2011-01-11 with 3 public-safe observations.

483· Form 483 issued3 observations

GE Medical Systems, LLC (dba GE Healthcare Specialty MR) · Wilmington, United States · Issued January 11, 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.

11 Jan 2011
21 CFR 820.40

Procedures not adequately established or maintained

Cited by John A Sciacchitano, Dawn M Braswell

11 Jan 2011
21 CFR 1002.10

Failure to submit, distinct marking

Cited by John A Sciacchitano, Dawn M Braswell

11 Jan 2011
21 CFR 1040.10(g)(1)(ii)

Class II "Caution" label

Cited by John A Sciacchitano, Dawn M Braswell

Inspected site

GMGE Medical Systems, LLC (dba GE Healthcare Specialty MR)Wilmington, United States

Inspection team

JAJohn A Sciacchitano
DMDawn M Braswell

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1002.10Cited across public-safe Form 483 observations1x
21 CFR 1040.10(g)(1)(ii)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited 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