FDA 483 - Cantrell Drug Company - August 22, 2018

During an inspection conducted from August 13 to August 22, 2018, the FDA identified significant deficiencies at Cantrell Drug Company, an outsourcing facility located in Little Rock, AR. These observations indicate a failure to adhere to current Good Manufacturing Practice (cGMP) regulations, which are critical for ensuring the quality and safety of drug products.The primary issues included unsuitable facility construction and inadequate environmental controls. Specifically, smoke studies revealed significant airflow turbulence near critical HEPA filters in ISO 7 classified rooms, failing to demonstrate proper air quality in ISO 5 environments. Furthermore, an air return vent in an ISO 8 room was not functioning correctly, compromising air cascading and potentially creating dead zones.Another major concern was the lack of adequate humidity control. The company's ISO rooms had an unscientifically justified upper humidity action limit above 65%, with actual monitored levels consistently exceeding 70% in one room without an established alert level to mitigate microbial growth risks.Finally, the inspection revealed insufficient controls over computer systems. Excel spreadsheets used for critical data trending, such as non-conformances and environmental monitoring, lacked safeguards against data manipulation and improper storage. Cantrell Drug Company is required to promptly address these observed deviations to ensure compliance with regulatory standards and uphold the quality and safety of its compounded drug products.