Form 483

GE Healthcare Inc. Form 483, 2024-03-08

FDA issued a Form 483 to GE Healthcare Inc. on 2024-03-08 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

GE Healthcare Inc. · Arlington Heights, United States · Issued March 8, 2024

Overview

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

Inspectional observations

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

8 Mar 2024
21 CFR 312.50

Ensuring compliance with plan and protocol

Cited by Kent A Conforti, Meredith L Miller

Inspected site

GHGE Healthcare Inc.Arlington Heights, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations1x

Full 483 report

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The full inspection record, as Atlas holds it, 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