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.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Contamination Concerns Land Raritan Pharmaceuticals a Form 483

Contamination Concerns Land Raritan Pharmaceuticals a Form 483

February 1, 2013

Raritan Pharmaceuticals’ East Brunswick, N.J., plant received a one-page Form 483 regarding concerns that distributed lots of one of its consumer products might be contaminated with clostridium difficile bacteria.

The company was notified Aug. 21, 2012, that gelatin raw material used to manufacture different versions of the product may have been tainted with the bacteria, the FDA said.

Raritan launched an investigation, still ongoing at the time of the agency’s September 2012 inspection one week later. But despite the ongoing probe, at least 10 finished product lots using the potentially contaminated material were shipped to the market, according to the form.

Don’t fret, we know just the thing to help you avoid similar situations. For more than 15 years, Drug GMP Report has provided thorough analysis and interpretation of ever-changing GMP regulations, FDA enforcement trends and warning letters, international regulations and more.

It’s like receiving a monthly executive briefing packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement. Why hassle yourself? Subscribe today!

Upcoming Events

  • 10Aug

    Gene & Cell Therapy Regulation: Comparability and Other New Developments

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

  • 22Sep

    FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Hyris T-Cell Test Gains CE-IVD Mark

  • FDA Expands Approval of Bayer’s Nubeqa for Prostate Cancer

  • MicroPort Navibot Receives 510(k) Clearance for Its SkyWalker System

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 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing