News & Blog

A response to an FDA Form 483 is an important regulatory step. But it is not necessarily the end of the process. A recent FDA Warning Letter issued to Bausch & Lomb Inc. provides a useful example of how the agency evaluates corrective and preventive actions (CAPA)—particularly when the underlying problems involve sterile manufacturing, contamination control, facility design, and the quality system. The warning letter followed an FDA inspection of Bausch & Lomb's Tampa, Florid

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