Quality

FDA Warns Euromi Over Complaint Handling

Belgium-based Euromi was slapped with a far-ranging FDA warning letter that chides the company for not properly handling complaints, including instances in which cannula tips from a liposuction system broke and became lodged in patients. Read More

Lawmakers Call on GAO to Investigate Power Morcellators

A bipartisan group of lawmakers is calling on the head of the U.S. Government Accountability Office to investigate why power morcellators remained on the market for more than two decades before being slapped with a black box warning last year. Read More

Liposuction Maker Hit With Warning Over Lax MDR

Belgium-based Euromi was slapped with a far-ranging FDA warning letter that chides the company for not properly handling complaints, including instances in which cannula tips from a liposuction system broke and became lodged in patients. Read More

Gap Analysis Critical for Combination Product cGMPs

To comply with FDA’s combination product good manufacturing practices, both devicemakers and drugmakers should first look at their systems and conduct a gap analysis using both the quality system regulation and drug cGMPs. Read More