Foreign vs. Domestic FDA inspection. Is it expected to be approached in the same manner?
The FDA in his reference document for FDA Investigators, GUIDE TO INSPECTIONS OF FOREIGN PHARMACEUTICAL MANUFACTURERS”, said that “One main difference that poses a significant challenge to the inspection team abroad is the logistics borne by the program itself.” See https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/foreign-pharmaceutical-manufacturers-596#Note Therefore, how do foreign manufacturers have to prepare a FDA inspection? An audit is mainly […]
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