US FDA Facility Compliance Actions Could Accelerate Despite Inspections Freeze
No longer in the field, inspectors have more time to wrap up work on previously completed facility evaluations, attorney Howard Sklamberg says. The inspections freeze could delay manufacturers’ abilities to bring facilities into compliance following adverse inspection findings, as well as agency reclassifications of facility status.
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"We're particularly concerned about the health care area right now because obviously that's driving everything now," says Tennessee AG Herbert Slatery III. He and CRN CEO Steve Mister spoke with HBW Insight about regulation of the consumer health marketplace with FDA suspending inspections of facilities operated by businesses manufacturing and marketing products subject to its oversight.
Exceptions will be made for inspections of facilities manufacturing medically necessary products, such as products to treat and prevent Covid-19, the disease caused by the virus, and breakthrough products such as cancer treatments.
Agency responds to COVID-19 pandemic's US arrival by suspending domestic surveillance inspections and non-critical for-cause and preapproval inspections.