Experts Predict Spike In Drug Recalls As US FDA Inspections Resume
Agency Expected To Focus Enforcement Efforts on COVID-19 Treatments
Legal experts 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.
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Compliance experts see possibilities in offering video tours as the FDA offers “holistic” approach to assessing sites during pandemic.
Demand surges, supply surges and investigator travel restrictions are forcing FDA to adopt less restrictive regulatory approaches during the pandemic.
Agency resuming domestic inspections with the help of a pandemic rating system to identify localities where inspections will be safest for investigators and plant workers. Another safety factor: all inspections will be pre-announced.