FDA WARNING_LETTER - Tri-Med, Inc. dba Advanced Care Infusion-Shelby - February 23, 2015

An FDA inspection of Tri-Med, Inc. (dba Advanced Care Infusion – Shelby) from February 12-23, 2015, revealed serious deficiencies in sterile drug product manufacturing, rendering products adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions. Observed violations included poor aseptic technique, such as operators touching non-sanitized equipment and inadequate glove sanitization before sterile manipulations. The firm failed to take remedial action or investigate positive viable air samples for bacteria and fungus, including a specific instance of fungus in the Buffer Room. Facility design issues were noted, with uncleanable painted cinderblock walls and unsealed, gapped ceiling tiles in aseptic processing areas. The HVAC system was deficient, lacking adequate air changes, pressure differentials between cleanroom areas, and verified HEPA filtration. Furthermore, the firm failed to demonstrate, through appropriate studies like dynamic smoke studies, that its ISO 5 laminar flow hoods provided adequate protection. While the firm responded to the Form FDA 483, its proposed corrective actions were deficient, lacking details on training, documentation for HEPA filtration, updated SOPs, cleanroom certification dates, and interim controls for continued operations. FDA strongly recommends a comprehensive assessment, potentially with a third-party consultant, and requires a written response within fifteen working days detailing corrective actions and timelines to prevent further legal action.