FDA WARNING_LETTER - Dignity Health - Northridge Hospital Medical Center - March 11, 2016

An FDA inspection of Dignity Health - Northridge Hospital Medical Center from February 16 to March 11, 2016, revealed serious deficiencies in sterile drug product manufacturing, posing patient risks. The facility's cleanroom design was inadequate, with an uncleanable ceiling, gaps, and separation from unclassified areas only by plastic strip curtains, lacking pressure gauges. There was no anteroom, and operators donned gowns in an unclassified area and washed hands in the cleanroom. Poor aseptic practices included operators not disinfecting gloves or materials before introducing them into ISO 5 from ISO 7 areas. The firm did not use sterile wipes for disinfection and failed to demonstrate adequate protection of ISO 5 areas by hoods. These conditions render drug products adulterated under section 501(a)(2)(A) of the FDCA.

The FDA acknowledged the firm's March 15, 2016, response to the Form FDA 483 but found some proposed corrective actions deficient. Specifically, the response did not indicate the use of sterile wipes for disinfectant application or the performance of smoke studies as part of routine certification. The FDA strongly recommended a comprehensive assessment of operations, including facility design, procedures, personnel, processes, materials, and systems, particularly aseptic processing, potentially utilizing a third-party consultant. The firm must respond within fifteen working days with specific corrective steps, an explanation of recurrence prevention, and supporting documentation. Failure to correct violations may result