FDA 483 - Vasamed, Inc. - May 16, 2019

An FDA inspection of Vasamed, Inc., a medical device manufacturer in Eden Prairie, MN, revealed significant deficiencies in its quality system. The firm was cited for inadequate procedures concerning design changes, incoming product acceptance, document control, and corrective and preventive actions. Additionally, device history records lacked required identification and labeling, indicating a failure to meet regulatory standards.