FDA 483 - Macbrud Corporation - January 23, 2020

Macbrud Corporation, a medical device manufacturer in Miami, FL, received a Form FDA-483 with eight observations following an inspection from January 21-23, 2020. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning design controls for their Specboard Jr. device, purchasing controls, incoming product acceptance, training, corrective and preventive actions, and nonconforming product procedures. One observation regarding purchasing controls was a repeat from a previous inspection.