FDA 483 - MannKind Corporation - August 06, 2021

An FDA inspection of Mannkind Corporation in Danbury, CT, revealed that the firm failed to adequately qualify and requalify various manufacturing equipment and utility systems. This included issues with verifying intended operating ranges for mixers, dryers, vision systems, and flow meters, as well as a potent compound facility system. These deficiencies indicate a lack of proper control and assurance of performance for equipment used in the manufacturing of non-sterile finished drug products.