FDA 483 - ACI HealthCare Limited - April 06, 2023

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from April 2 to April 6, 2023, ACI HealthCare Limited, a drug product manufacturer located in Narayanganj, Bangladesh, received an FDA Form 483 detailing an observation related to inadequate storage conditions. The primary issue identified was that drug products and raw materials were not stored under appropriate temperature and humidity conditions, which could compromise their identity, strength, quality, and purity. Specifically, the inspection found deficiencies in the firm's warehouse temperature mapping studies. For the finished product warehouse, the summer temperature mapping conducted in April 2018 did not represent worst-case summer temperatures, failing to adequately challenge the HVAC system. Similarly, for the raw material warehouse, the May 2018 summer mapping was not representative of the hottest periods. Although a re-mapping was performed due to an observed humidity excursion, it was limited to only a section of the warehouse, rather than addressing the entire facility under worst-case summer conditions. These observations indicate a failure to ensure environmental controls crucial for maintaining product integrity, a fundamental requirement under current Good Manufacturing Practices (GMP) for drug products. ACI HealthCare Limited is expected to implement prompt corrective actions to address these deficiencies and ensure compliant storage environments for all regulated materials.