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Warning Letters Mount As FDA Completes Initial Inspections Of Under-The-Radar Facilities

 
• By Joanne S. Eglovitch

Later this year, FDA expects to complete initial inspections of every facility that manufactures drugs for the US market. As the agency visits under-the-radar facilities recently targeted as part of an effort to leave no site uninspected, it is finding that they are more likely to have serious drug GMP issues.

Ban Pills

US FDA has made much progress over the past year in reducing the inventory of firms it has never inspected even though they market drug products or ingredients in the US, Alonza Cruse, who directs the Office of Pharmaceutical Quality Operations in the agency’s Office of Regulatory Affairs, told a June 4 meeting of the International Society for Pharmaceutical Engineering in Arlington, Virginia.

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