We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Italian Agency Hits Chinese Heparin Manufacturer for GMP Violations

Italian Agency Hits Chinese Heparin Manufacturer for GMP Violations

RedWarningStamp.gif
January 11, 2019

The Italian Medicines Agency found serious GMP violations during an Oct. 31 inspection of a heparin manufacturing facility in China and recommended that the firm be prohibited from supplying crude heparin sodium to the EU.

The agency’s inspectors found the Yibin Lihao Bio-Technology facility in Sichuan failed to adhere to GMP requirements for active substances in its procedures for drying, primary packaging and secondary packaging. It also found problems with the facility’s testing.

The Italian officials noted 24 GMP deficiencies, including seven categorized as major. The major violations involved contamination risks, issues with buildings and facilities, storage of starting materials, material management, solvent recovery and equipment.

View today's stories

Pharmaceuticals Inspections and Audits

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Acquires -Acquired

    Amgen to Buy Five Prime Therapeutics for $1.9 Billion

  • abbott-logo.gif

    Abbott Secures EUA for COVID-19 Combination Test

  • Eli Lilly logo

    Eli Lilly’s COVID-19 Antibody and Combo Therapy Gets Positive EMA Recommendation

  • AdaptiveBiotechnologies_Logo.png

    FDA Grants EUA for Adaptive Biotechnologies’ T Cell COVID-19 Test

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing