The FDA recently issued Warning Letters to two overseas medical device manufacturers, citing significant violations of the Quality System Regulation (QSR) . This action is not a mere administrative notification; it sends a powerful message that the FDA is actively stepping up scrutiny of overseas manufacturing operations and their capacity for effective quality system management. Both companies were found to have systemic failures in product testing and validation procedures,

A Look at U.S. Market Regulations Through a Recent FDA Warning Letter “An FDA warning letter? That's only for big corporations, right?”...