FDA 483 - Texas Injection Molding, LLC - March 21, 2024

Texas Injection Molding, LLC, a medical device contract manufacturer in Houston, received a Form FDA-483 following an inspection. The observations primarily concern deficiencies in process validation for their blow molding operations, inadequate establishment and execution of equipment preventive maintenance, and a lack of a comprehensive Device History Record procedure for medical device lots. These issues indicate significant gaps in their quality system.