FDA 483 - Gutizmultiservices Inc - September 29, 2022

Gutizmultiservices Inc. in Pembroke Pines, FL, was inspected as a medical device manufacturer and received a Form FDA 483 with five observations. The inspection revealed significant deficiencies in the firm's quality system, primarily concerning the lack of established procedures for critical processes such as corrective and preventive actions, complaint handling, device history records, nonconforming product disposition, and medical device reporting. These issues indicate a fundamental absence of a robust quality management system.