Closer Scrutiny of Suppliers Might Have Averted Big Food Recalls
This article was originally published in The Gold Sheet
LESSONS CITED FROM MAJOR FOOD RECALLS include the importance of monitoring the supply chain and being alert to subtle signs of problems, especially when new suppliers are involved. However, the nature of the food and chemical industries makes it difficult to control the supply of pharmaceutical excipients. Demanding traceability could be one answer. Supplier qualification could be another.
You may also be interested in...
The US FDA shaved months from review of Gilead’s Veklury (remdesivir) for COVID-19 with post-approval commitments for multiple stability studies. The Pink Sheet takes a deep dive look at discussions within the agency and with the sponsor.
FDA historically has based 100% of drug adulteration warning letters on inspections but COVID-19-related travel restrictions began changing that in FY 2020, when 2% of drug GMP warning letters were based on testing import samples. The change became even more pronounced in the first two months of FY 2021, with 59% of actions related to sample testing and 41% to inspections.
Government offers help securing supplies in return for another 100 million doses by Q2. That would mean abandoning Pfizer’s preferred arms-length relationship.