Other Human Disease — Worldwide/Unknown
Overview
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The agency recently took a critical look at our surveillance and enforcement approach to pharmacies that produce sterile drug products. The agency’s objective was to determine whether certain pharmacies that were known to have produced high-risk sterile drug products in the past posed a significant threat to public health from poor sterile drug production practices.
Using a risk-based model, FDA identified 29 firms for priority inspections that focused on their sterile
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