FDA 483 - ACI HealthCare Limited - April 01, 2022

An FDA inspection of ACI HealthCare Limited in Narayanganj, Bangladesh, revealed critical deficiencies in the firm's quality control and data integrity programs. Observations included incomplete laboratory records, a lack of written procedures for the quality control unit, and inadequate investigations into out-of-specification results. These issues indicate a significant failure to maintain proper control over manufacturing and testing operations for finished drug products.