FDA 483 - ACI HealthCare Limited - April 06, 2023

ACI HealthCare Limited, a drug product manufacturer in Narayanganj, Bangladesh, was cited for failing to store drug products under appropriate temperature and humidity conditions. The inspection revealed deficiencies in the firm's warehouse temperature mapping studies for both finished drug products and raw materials, as the studies did not represent worst-case summer temperatures. This raises concerns about the identity, strength, quality, and purity of the stored products.