US FDA Suspends Domestic Inspections As Staff Work Remotely In Covid-19 Response
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.
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Warning letters show FDA's coronavirus investigations inthe consumer health marketplace didn't stop when it suspended facility inspections. The letters identify firms that previously marketed only bedding products as offering supplements with coronavirus claims or that are in other countries and are shipping to US consumers products promoted with coronavirus claims.
"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.
Supplement manufacturers should increase vigilance over supply chains after FDA suspends routine facility inspections and certain requirements of its foreign supplier verification program. Firms should verify even their trusted supplier’s next few certificates of analysis and step-up adverse event monitoring.