MannKind Corporation – FDA 483, Aug 6, 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.
ID · 686b387a-aa0f-4dfa-8b56-6f3748f18934
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.