Supplement Firms Should Tighten Supply Gatekeeping As FDA Suspends Inspections
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.
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Latest warnings also include second and third businesses in US cannabidiol and hemp sector found making unlawful claims for treating and preventing COVID-19. Four of five firms warned apparently responded by removing violative claims from websites and social media posts.
Issued as part of the new approach to releasing guidances during the pandemic, FDA said flexibility was needed for two reasons: anticipated higher levels of absenteeism among staff for both sponsors and the agency, and the necessity of prioritizing a focus on adverse events for products used to treat coronavirus.
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.