A recent Forbes article noted that the FDA will make an exception and forgo Covid-19 vaccine manufacturing plant inspections. According to the FDA Director of Viral Products, as candidates approach the final phase of testing, emergency use authorization will be granted without pre-approval inspections. Under normal circumstances, it is required that the FDA inspect several batches of vaccines to ensure they are made with the same safety, consistency, and potency standards.
FDA Won’t Inspect Covid-19 Vaccine Plants
Vaccine manufacturers will get a rare pass from FDA plant inspections prior to approval.
Nov 5th, 2020