Regulatory Roundup: FDA Takes Action Against Drug Manufacturer and Distributor - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Regulatory Roundup: FDA Takes Action Against Drug Manufacturer and Distributor

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA has issued a consent decree of condemnation, forfeiture, and permanent injunction against H&P Industries, The Triad Group, and three individuals to prevent them from manufacturing and distributing products from their Wisconsin facility and other locations. “The Triad Group distributes and H&P Industries manufactures a variety of over-the-counter drug products including povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, and hemorrhoidal wipes,” according to the agency announcement. H&P had failed to comply with cGMPs as demonstrated in inspections conducted by FDA between 2009 and 2011, and has initiated five product recalls because of bacterial contamination since December 2010. Operations cannot be resumed until the companies prove to have an acceptable Quality Assurance and Quality Control program.

The agency also approved redesigned drug container label produced by Merck that address a new standardized format aimed at improving readability and understanding of product and strength differentiation, according to an FDA release. The company’s labeling project included revising 34 container labels for 16 solid oral drugs.

The International Conference on Harmonization steering committee and expert working groups held one of their twice-annual meetings last week in Cincinnati, Ohio. Summaries of the meeting are expected soon.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here