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The Quality Lowdown: US FDA Renews Attention To Contamination Challenges

 
• By Bowman Cox

All-out efforts by agency staff to help industry supply COVID-19 treatments last year were applauded but now its attention returns to the top pre-pandemic priority, contamination risks. Edge Pharma consents to attack mold, Glicerinas blocked over inspection refusal, Bioiberica hit for ‘reprocessing’ contaminated drug substance, Rentschler bashed for inadequate monitoring.

The Quality Lowdown

Even as US Food and Drug Administration leadership praised staff for last year’s quick reactions to COVID-19 pandemic supply chain risks, recent inspection findings show that the agency’s attention has switched back to focusing on contamination risks.

These include a compounding pharmacy that signed a consent decree after failing to quell fungal contamination, and a drug substance manufacturer in Spain that was questioned about its unusual response...

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