Endo Health’s Transvaginal Mesh Unit Lands FDA Warning Letter on CAPA

A Minnesota-based unit of Endo Health Solutions has landed an FDA warning letter, the Irish devicemaker says in a Wednesday SEC filing. The warning letter stems from a February inspection of the company’s American Medical Systems plant in Minnetonka, Minn., that generated a three-observation Form 483 on Feb. 24.
Devices & Diagnostics Letter