Inventive Infusion Solutions, LP – FDA 483, Aug 31, 2018

An FDA inspection conducted from August 20-31, 2018, at Inventive Infusion Solutions, LP, a manufacturer of sterile and non-sterile drugs in San Antonio, Texas, identified critical deficiencies in their manufacturing operations. The observations, documented on an FDA Form 483, indicate several deviations from Current Good Manufacturing Practices (CGMP).Significant issues included the failure to properly use biological indicators to verify the adequacy of sterilization cycles for pellet drug products, and the absence of endotoxin testing for finished intrathecal drug products and bulk drug substances, raising patient safety concerns. The firm also used non-sterilized and inadequately depyrogenated equipment in sterile drug production, without establishing hold times for cleaned items. Aseptic production operations were not effectively challenged by media fills, which failed to simulate actual conditions.Further observations highlighted inadequate personnel disinfection practices in ISO 5 areas and a lack of specific procedures for containment, segregation, and cleaning to prevent cross-contamination of beta-lactam drugs. Environmental control was compromised by unsealed ceiling tiles in the ISO 7 cleanroom, and non-sterile disinfecting agents were inappropriately used in ISO 5 aseptic processing areas. These findings require Inventive Infusion Solutions, LP, to implement robust corrective and preventive actions to ensure product quality, safety, and full regulatory compliance.