Martin Marietta Inc – FDA 483, Aug 21, 2026

Martin Marietta, an API manufacturer in Greendale, IN, received a Form 483 with six observations highlighting significant deficiencies in their manufacturing processes. Issues included inadequate cleaning validation procedures, poor facility sanitation with unsecured insulation, and incomplete batch production records. The firm also failed to ensure the suitability of raw materials through proper testing and did not adequately evaluate critical material suppliers or verify their Certificates of Analysis.