Attention www.globalkeysolutions.net is now www.keypedia.com, read the full press release here.
KeyPedia LogoKeyPedia Icon
  1. Home
  2. /
  3. Records
  4. /
  5. 483
  6. /
  7. GE Healthcare Inc. - Life Sciences
483
•GE Healthcare Inc. - Life Sciences•March 8, 2024

FDA 483 - GE Healthcare Inc. - Life Sciences - March 08, 2024

View on Dashboard

Your cart

Your cart is empty.

Browse public document pages and click Buy this document. We'll ask for your email at checkout, no account needed up front.

Browse documents

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Record Details

An FDA inspection of GE Healthcare Inc. - Life Sciences in Marlborough, MA, identified a significant issue related to the conduct of a clinical investigation. The firm failed to ensure that a study was carried out according to its general investigational plan and protocols. Specifically, data from subjects with uninterpretable image quality were improperly included in the Intent to Treat analysis, compromising the study's integrity.

Company
GE Healthcare Inc. - Life Sciences
Inspection Date
March 8, 2024
Product Type
Other
Office
New England District Office
People
  • Kent A. Conforti (issuing_officer)
  • Meredith L. Miller
Open in Dashboard

ID · 12ab724a-fff6-47f9-b5e2-58b34c7adf59

footer
Global Key Solutions
Regulatory Data Transformed
Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
info@globalkeysolutions.net
Quick Links
HomePlatform OverviewMedia
KeyPedia™ Lite
Browse HubDatabase DirectoryRecordsCompaniesOfficesPeopleCareersAbout UsFounding TeamMeet Our ExpertsPartners
Legal & Ethics
Privacy PolicyTerms of ServiceOur Values & MissionCode of Ethics & AI Policy
©2026, Global Key Solutions All rights reserved.