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 » Singapore Firm Draws Warning for Unapproved Drug, Quality Violations

Singapore Firm Draws Warning for Unapproved Drug, Quality Violations

April 26, 2019

Luen Fook Medicine’s Singapore facility drew a warning letter from the FDA for making unapproved drug claims and for repeat quality violations.

The FDA inspected the facility from Dec. 10-14, 2018 and deemed the company’s African “Sea Coconut” sore throat syrup to be an unapproved new drug because of its formulation and labeling. The product was marketed as a demulcent for relief of minor pain and inflammation.

The agency also flagged a problem with the active ingredient. Over-the-counter drug products for use as a demulcent are subject to the tentative final monograph for Oral Health Care Drug Products for Over-the-Counter Human Use. The monograph permits elm bark only in a solid dosage form at a concentration of 10-15 percent — but the sore throat syrup listed 65 milligrams of elm bark in each five-milliliter teaspoon in a liquid dosage form.

The FDA also blasted the firm’s quality unit for failing to properly oversee active ingredient testing, cleaning validation and process validation.

View today's stories

Pharmaceuticals Inspections and Audits

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

  • BioVentrix gets Expanded Access Approval for Left Ventricle Support System

  • FDA Approves Stemline’s Orserdu for Several Forms of Breast Cancer

  • FDA Issues Update on LivaNova Recall of Blood Pumping System

  • EU Expands Dupixent’s Authorization to Include Eosinophilic Esophagitis

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