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. SGS France
483
•SGS France•August 29, 2025

FDA 483 - SGS France - August 29, 2025

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 SGS France Life Sciences in Saint Benoit, France, revealed significant deficiencies in their bioanalytical facility's method validation and study sample activities. Observations included an analytical method lacking sufficient specificity, incomplete reporting of rejected analytical sequences, and non-contemporaneous documentation of experiments. Additionally, the firm failed to follow established SOPs regarding deviation documentation, indicating systemic issues with data integrity and quality control.

Company
SGS France
Inspection Date
August 29, 2025
Product Type
Drugs
Office
Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People
  • Xingfang Li, MD, RAC, Pharmacologist
  • Ruben C. Ayala, PharmD, Lead Pharmacokineticist
  • Ruben C. Ayala (investigator)
  • Xingfang Li
Open in Dashboard

ID · 6edc34f4-69ed-480c-abd7-a70c0cb64de4

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.