FDA 483 - A.P. Deauville, LLC - January 23, 2025

An FDA inspection conducted at Mylan Institutional LLC's sterile drug product manufacturing facility in Rockford, IL, from November 27 to December 15, 2023, revealed significant deficiencies in compliance with current Good Manufacturing Practice regulations. This inspection, which included repeat observations from prior 2017 and 2021 inspections, highlighted critical issues impacting product quality and patient safety.Key violations include inadequate investigations into unexplained discrepancies and batch failures, such as a failed sterility test for Levothyroxine Sodium for Injection where a root cause was not identified, and manufacturing investigations closed without addressing high reject rates. The facility also lacked robust laboratory controls, specifically failing to validate test methods for assay and impurity testing of Levothyroxine Sodium for Injection and not establishing procedures for component identity testing.Furthermore, aseptic process validation for the filling machine was found insufficient, as it did not simulate normal production interventions or qualify the maximum batch size. The firm also lacked a comprehensive stability testing program for drug products like Levothyroxine Sodium for Injection, omitting initial commercial batches and impurity testing. Finally, the quality control unit failed to follow its own procedures for timely reporting of significant quality issues, delaying a Field Alert Report submission for an out-of-specification stability result.Mylan Institutional LLC is required to implement comprehensive corrective and preventive actions to rectify these systemic issues, ensuring thorough investigations, validated laboratory controls, robust aseptic processing, complete stability programs, and adherence to quality reporting procedures to meet regulatory standards.