Coram Healthcare Corp. of Indiana – FDA 483, Apr 26, 2017

Coram Healthcare Corporation of Indiana, a producer of sterile drug products, underwent an FDA inspection from April 17-20 and April 25-26, 2017. The inspection resulted in a Form FDA 483 listing significant observations related to aseptic processing and facility controls. Key violations included inadequate disinfection practices for equipment and materials entering aseptic processing areas. Specifically, sterile drug product vials were placed directly under an ISO-5 hood without prior cleaning, and materials were handled without proper gloving or disinfection during transfers. The firm also demonstrated inadequate use of sporicidal agents in cleanrooms, lacking sufficient cleaning frequency assessments and data to support established contact times for sporicidal activity. Furthermore, inadequate cleaning procedures for beta-lactam drugs raised concerns about cross-contamination, particularly as these products were processed in shared ISO-5 hoods without dedicated areas—a deficiency noted as a repeat observation. Finally, aseptic environmental conditions were not assured, as the firm's dynamic smoke study video failed to accurately represent actual processing operations, potentially compromising laminar air flow. Coram Healthcare Corporation of Indiana is expected to implement robust corrective actions to address these critical deficiencies and ensure compliance with good manufacturing practices for sterile drug production.