FDA 483 - embecta Medical II LLC - June 03, 2026

An FDA inspection of embecta Medical II LLC in Parsippany, NJ, a medical device manufacturer, revealed significant deficiencies across multiple quality system areas. The firm failed to adequately validate device designs, submit timely Medical Device Reports (MDRs) for malfunctions, and establish proper controls for outsourced manufacturing processes. Additionally, issues were noted in updating risk documentation with post-market data and in the thorough investigation and handling of product complaints.