FDA Closes Contract Drug Manufacturer
Posted on: Friday, 16 May 2008, 12:00 CDT
The U.S. Food and Drug Administration said it obtained a permanent injunction preventing the production of drugs by Scientific Laboratories Inc.
The FDA said the Columbia, Md., company -- a contract manufacturer and distributor of various prescription cough and cold products -- violated federal laws by failing, among other things, to seek required FDA approval for some of its products and failing to comply with current good manufacturing practice requirements.
The unapproved drugs manufactured and marketed by Scientific Laboratories as prescription cough and cold products include: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid and Nazarin HC Liquid.
The FDA said the consent decree subjects the company to liquidated damages in the amount of $5,000 per day if they fail to comply with any of the provisions of the decree, and an additional sum of $5,000 for each violation, up to $1 million per year.
Source: United Press International
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