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 » Indian Drugmaker Nailed for Falsifying Data

Indian Drugmaker Nailed for Falsifying Data

May 29, 2019

A Gujarat, India finished drug manufacturer drew a warning letter from the FDA after an inspection turned up serious violations at its facility, including shredded and falsified data.

The agency’s Oct. 22-26, 2018 inspection of Centurion Laboratories’ site revealed torn up stability study data, analytical testing sheets, release forms and analysis calculations found in trash bags. Test results were recorded as within specification despite the out-of-specification results found in the trash. The company prepared and pre-signed blank stability study forms before recording the test data.

The FDA investigators also found issues with cleaning at the facility that created risks of cross-contamination and inconsistent drug products. In one room, a piece of equipment was marked as “cleaned,” but the equipment had visible product buildup inside and its air filter was damaged with multiple holes. The company explained that it was short on staff members because of a nine-day dancing festival.

View today's stories

Pharmaceuticals Regulatory Affairs

Upcoming Events

  • 01Feb

    The Future of QMS: Will the Recent Announcement and Delays Have a Global Impact?

  • 08Feb

    Process and Design Validation for Devicemakers: A Deep Dive into Best Practices, Recent Trends and Regulatory Definitions

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 22Feb

    Best Practices for Developing and Maintaining a GxP Training Matrix

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

  • NeuroMetrix Launches DPNCheck 2.0 for Peripheral Neuropathy Screening

  • Syros Gets Fast Track Status for Higher-Risk Myelodysplastic Syndrome Candidate

  • FDA Approves Abbott’s Spinal Cord Stimulation System for Diabetic Peripheral Neuropathy

  • FDA Expands Approval for Merck’s Keytruda in NSCLC

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 or Share My Data
Footer Logo

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

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing