FDA 483 - Schoelly USA Inc - December 01, 2021

An FDA inspection of Schoelly USA Inc. in Northborough, MA, identified one observation related to inadequate environmental control procedures. Specifically, the firm lacked established procedures for controlling electrostatic discharge (ESD) or electrical overstress (EOS) regarding the testing, approval, and use of a screwdriver at a designated ESD station. This indicates a moderate severity issue concerning quality system requirements for device manufacturing.