Complete Response Letters In Lieu Of Inspections: What To Expect During COVID-19
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Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.
Attorneys and recall consultants say any firm distributing products associated with COVID-19 should expect to receive the highest level of scrutiny as the US FDA resumes inspections and uses its enforcement muscle to prohibit companies from making adulterated products, such as hand sanitizers, or making fraudulent claims.
Compliance experts see possibilities in offering video tours as the FDA offers “holistic” approach to assessing sites during pandemic.