FDA 483 - fusion iv pharmaceuticals, inc. - March 23, 2017

An FDA inspection conducted at Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical in Los Angeles, CA, from March 13-23, 2017, revealed significant deficiencies in the production of sterile drug products. The observations highlight critical lapses in the firm's adherence to quality standards and regulatory requirements for an outsourcing facility.Major issues included a failure to establish adequate procedures to prevent microbiological contamination. This involved not investigating media fill sterility failures, omitting media fill validations for automated filling equipment, and lacking smoke pattern tests in critical aseptic areas. Personnel practices also compromised sterility. Furthermore, the firm failed to adequately validate sterilization processes for equipment and drug product containers, with critical temperature criteria not consistently met and biological indicator incubation records being insufficient or missing.Other key violations encompassed deficient environmental monitoring in aseptic processing areas, inadequate laboratory testing for sterility and antimicrobial effectiveness, and non-compliant drug product labeling. Specifically, labels for numerous sterile drug products lacked the required "Office use only" statement as mandated by Section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act. The facility also failed to submit the initial product compounding report to the FDA, a requirement under Section 503B(b)(2)(A). Fusion IV Pharmaceuticals is required to address these observations promptly through comprehensive corrective actions to ensure patient safety and regulatory compliance.