FDA 483 - Myerson LLC - May 04, 2021

Myerson LLC, a device manufacturer in Chicago, IL, received a Form FDA 483 with eight observations. The inspection revealed significant deficiencies in medical device reporting, complaint handling, corrective and preventive actions, device history records, design validation, design history files, and finished device acceptance procedures, particularly concerning their Elastic Mandibular Advancement (EMA) device. These issues indicate a lack of adherence to quality system regulations and timely reporting requirements.