FDA 483 - MUMEASE LLC - April 01, 2021

MumEase LLC, a medical device manufacturer in Charlotte, N.C., received an FDA Form 483 with 13 observations following an inspection. The findings indicate widespread deficiencies in the firm's quality system, particularly concerning design controls, device history records, labeling, and overall quality management processes. These issues suggest a significant lack of adherence to regulatory requirements for their nausea-relieving acupressure bracelets.