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The Quality Lowdown: US FDA Renews Attention To Contamination Challenges

Executive Summary

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.

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