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Statement from FDA on continuing efforts to maintain its strong oversight of generic drugs
date:Feb 25, 2019
ity to leverage inspectional work done by trusted partners, especially in Europe; and a higher number of pre-approval inspections.

Our policy for prioritizing and scheduling drug manufacturing inspections at higher risk facilities for quality-related surveillance is based on a facilitys compliance history, recall trends, time since last inspection, inherent risk of the drug being manufactured, processing complexity, and other factors, which are all carefully weighed and considered. When you loo

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