Tri-Med, Inc. dba Advanced Care Infusion-Shelby – FDA 483, Feb 23, 2015

Tri-Med, Inc. dba Advanced Care Infusion-Shelby received an FDA Form 483 following an inspection from February 12-23, 2015, highlighting significant deficiencies in its sterile drug product manufacturing operations.

Key violations included inadequate environmental control and monitoring, with observations such as insufficient cleaning and disinfection protocols (lacking sporicidal agents, using non-sterile wipes), deficient air handling systems (inadequate positive pressure, low air changes per hour, untested HEPA filters), and non-smooth, difficult-to-clean surfaces in aseptic areas. The environmental monitoring program was found lacking in routine sampling, dynamic condition representation, and comprehensive media for detecting contaminants, alongside absent routine monitoring of pressure differentials and personnel.

Aseptic processing and sterility assurance failures were critical, encompassing inadequate process simulations, poor aseptic techniques by personnel (e.g., bare hands in critical zones, insufficient sanitization), and inappropriate gowning practices (non-sterile attire, exposed skin, gowns not dedicated to clean areas). The firm also failed to adequately investigate contamination discrepancies, including significant bacterial and fungal findings in cleanroom air samples.

Furthermore, substantial gaps existed in product testing and quality control. The company did not perform essential sterility, endotoxin, or potency testing for many sterile drug products, and its in-house sterility test was deemed scientifically invalid. A written stability program was absent, leading to unsupported Beyond-Use Dates for critical products. Many fundamental quality control procedures were either unwritten, inadequate, or not strictly followed, relying instead on undocumented verbal modifications.

These observations indicate severe non-compliance with current Good Manufacturing Practices (cGMP) for sterile drug products. Tri-Med, Inc. must undertake immediate and comprehensive corrective and preventive actions to rectify these systemic issues, ensuring the sterility, quality, and safety of its drug products to meet federal regulatory standards.