FDA 483 - Cantrell Drug Company - August 22, 2018

An FDA inspection of Cantrell Drug Company, an outsourcing facility in Little Rock, AR, was conducted from August 13 to August 22, 2018. The inspection identified critical issues related to facility design, environmental controls, and data integrity. Firstly, the physical construction of manufacturing areas was found to be unsuitable; smoke studies revealed significant air turbulence in ISO 7 and ISO 8 classified rooms, compromising proper air cascading and potentially affecting ISO 5 environments. Secondly, the company lacked adequate control over humidity in drug manufacturing areas. The established upper action limit for relative humidity exceeded 65% without scientific justification, and monitoring showed consistent levels above 70% in certain rooms since May, with no alert levels established. Finally, insufficient controls were observed over computer systems. Specifically, Excel spreadsheets used for managing critical data, including non-conformances, weight checks, and environmental monitoring, lacked appropriate safeguards to prevent unauthorized data manipulation and ensure secure storage. Cantrell Drug Company is expected to address these observations by implementing comprehensive corrective actions to comply with regulatory standards.