Regulatory Roundup: FDA Takes Action Against Drug Manufacturer and Distributor

Jun 16, 2011
By PharmTech Editors

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.