Angel Medical Systems, Inc. – FDA 483, Mar 28, 2022

Angel Medical Systems, Inc., a medical device manufacturer in Eatontown, NJ, was cited for several quality system deficiencies during an FDA inspection. The observations highlight inadequate procedures for corrective and preventive actions, lack of process controls for reprocessed devices, insufficient design verification documentation, and issues with supplier management. These findings indicate a need for the firm to improve its adherence to quality system regulations.