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FDA finds sterile deficiencies at some compounding pharmacies
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Numerous safety issues were uncovered during recent inspections of 31 compounding pharmacies in 18 states by the FDA, the agency announced Thursday.
Among the safety deficiencies reported were “unidentified black particles floating in vials of supposedly sterile medicine; rust and mold in ‘clean rooms’ … technicians handling supposedly sterile products with bare hands; and employees wearing nonsterile lab coats,” according to a Thursday post on the agency’s blog by FDA Commissioner Margaret A. Hamburg, MD.
Hamburg said the agency was determined to act aggressively to help ensure there is no repeat of last year’s deadly fungal meningitis outbreak caused by the mold pathogen Exserohilum rostratum in tainted vials of methylprednisolone produced by the New England Compounding center. That outbreak eventually claimed at least 50 lives.
Margaret A. Hamburg
Hamburg said several firms have voluntarily recalled or suspended production of some products due in part to the FDA’s observations during 7 weeks of inspections.
“It may surprise some people to know that, even in light of the recent tragic events, some of the firms we inspect still challenge our authority to conduct full inspections of their facilities,” said Hamburg, adding that four of the 31 facilities initially refused access to FDA investigators.
The agency said it is still evaluating inspection reports and may take additional action to protect public health, coordinated with state boards of pharmacy.