This is the second post in a series covering recurring FDA Import Alert patterns by industry. Part 1 covered food and dietary supplements; this one covers medical devices. Read More:: Container Stuck at a U.S. Port — What Triggers an FDA Import Alert for Food and Supplements Even companies with a 510(k) clearance sometimes find their shipments held at customs — and this question keeps coming up in medical device inquiries. Clearance and the ability to actually clear customs a

This post is the first in a series on recurring FDA Import Alert patterns by industry. This installment covers food and dietary supplement cases; the next covers medical devices. Read more:: Trapped in Customs: The Hidden Triggers Behind FDA Import Alerts for Medical Devices Three days after his container cleared Busan and reached the Port of LA, the exporter got a frantic call from his U.S. buyer. Customs wouldn't release the shipment. The paperwork from FDA mentioned someth

In June 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Huons Co., Ltd. following an inspection of its sterile injectable manufacturing facility in Jecheon, South Korea. While Warning Letters are not uncommon in the pharmaceutical industry, this case stands out because it goes far beyond isolated documentation issues. The FDA concluded that the company's manufacturing systems, laboratory controls, and quality oversight failed to comply with Curren

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?”...