FDA WARNING_LETTER - Coram Healthcare Corp. of Indiana - December 16, 2014

From December 1 to December 16, 2014, the FDA inspected Coram Healthcare Corporation of Indiana, dba Coram CVS/Specialty Infusion Services, in Crown Point, IN. The inspection revealed serious deficiencies in sterile drug product production, posing patient risks.

Violations included inadequate aseptic practices, such as operators not sanitizing gloves before placing hands under the ISO 5 laminar flow hood (LFH), and resting gloved hands on the LFH workbench. The firm also failed to adequately clean and disinfect work surfaces, supplies, and equipment in aseptic processing areas. Specifically, beta-lactam products were processed under the same LFH as non-beta-lactam products, and the firm lacked data to support the effectiveness of their beta-lactam spill cleanup procedure. Furthermore, the firm failed to demonstrate, through appropriate studies like dynamic smoke studies, that the ISO 5 LFH provides adequate protection for sterile product processing. These conditions render the drug products adulterated under section 501(a)(2)(A) of the FDCA.

Coram's January 23, 2015, response to the FDA-483 referenced USP <797> compliance and claimed exemption under section 503A, but failed to provide sufficient documentation or detail for their corrective actions. The FDA strongly recommended a comprehensive assessment of operations, including facility design, procedures, personnel, processes, materials, and systems