Lately, the FDA has been issuing a wave of Warning Letters to OTC sunscreen manufacturers. Korean manufacturers are no exception. Across all these letters, the core issue remains exactly the same: It’s not just about a faulty product; the entire manufacturing quality system is failing to function. In South Korea, sunscreen is classified as a "functional cosmetic." Because of this, many brands and manufacturers mistakenly assume: "We passed the SPF testing, so we should be fin

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?”...