FDA EIR - Vesta Inc. - January 31, 2020

An FDA inspection of Vesta Inc., a medical device contract manufacturer in Franklin, WI, was conducted from January 27-31, 2020. The inspection, guided by Compliance Program 7382.845 for medical device manufacturers, focused on Vesta's quality system, including production, process activities, and design controls for various Class I, II, and III medical devices. While no FDA Form 483 (Inspectional Observations) was issued during this inspection, four critical areas were verbally discussed with management for improvement. These included the necessity for a clear procedure regarding deviations and consistent adherence to written processes, a defined procedure for preventative actions to ensure effectiveness verification, documentation of product destruction methods, and clarification in the leak testing procedure regarding specific equipment sizes. Vesta Inc. also has a production hold on a Class III medical device due to ongoing valve test failures and an undetermined root cause. Management committed to addressing all verbally discussed items, underscoring their responsibility to comply with Quality System Regulations and continuously monitor facility compliance through internal audits and management reviews. Previous 483 observations from a 2017 inspection concerning process validation and environmental monitoring were noted as corrected.