FDA 483 - Remote Technologies, Inc. - November 08, 2023

An FDA inspection of Remote Technologies, Inc., a medical device manufacturer in Greenwich, CT, identified two significant observations. The firm failed to maintain written Medical Device Reporting (MDR) procedures, specifically lacking eMDR procedures and an Electronic Submissions Gateway (ESG) account. Additionally, the device master record was not adequately maintained, as it did not document the use of a specific tag for repair and rework operations.