FDA 483 - Anschel Technology Inc. - December 31, 2019

Anschel Technology Inc. in Rocky Point, NY, a medical device specification setter, was inspected by the FDA from December 19-31, 2019. The inspection revealed two significant issues: a lack of maintained written electronic Medical Device Reporting (eMDR) procedures and deficiencies in device history records regarding Unique Device Identifiers (UDI) for their Class II medical devices. These observations indicate a need for improved quality system compliance.