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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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.
US manufacturers losing ingredient supplies from China may need to qualify more suppliers, potentially requiring tests of all lots, says EAS Consulting. Contract and other manufacturers also should identify alternative sources for materials they receive from China and prepare for shortages from other countries.