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. Henogen SRL
483
•Henogen SRL•November 22, 2024

FDA 483 - Henogen SRL - November 22, 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 Henogen SRL, a viral vector manufacturer in Seneffe, Belgium, revealed a significant deficiency in control data related to the manufacturing of viral vectors. Specifically, the firm's batch records lacked adequate reconciliation of production yield and criteria for investigating excessively high or low yields. This indicates a potential lack of robust process control for critical manufacturing steps.

Company
Henogen SRL
Inspection Date
November 22, 2024
Product Type
Biologics
Office
Office of Inspections and Investigations
People
  • Scott T. Ballard
  • Priscilla M. Pastrana (investigator)
Open in Dashboard

ID · 2b8c2510-c4d6-4ff8-995d-f8e56407bf37

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
KeyPedia™ Lite
Legal & Ethics
©2026, Global Key Solutions All rights reserved.