In Covid-19 Storm, Supplement Manufacturers' Safe Harbor Could Be Qualifying New Suppliers
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.
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'We've got be sure that companies can continue to get ingredients for their products," says CRN CEO Steve Mister, Concern supplies from India, which is a week into a a three-week nationwide lockdown, and other potential supply chain problems were noted by CRN members in a survey it conducted to help USDA gauge global food and nutrition ingredient supply chains during the pandemic.
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.
The Covid-19 pandemic could push food and supplement manufacturers to switch to manufacturing OTC or Rx drugs to help fill public health gaps, says a former deputy director of FDA's Office of Dietary Supplement Programs. Many marketers are well equipped to make OTC drugs, he added in FDLI webinar.