FDA 483 - Calumet Karns City Refining LLC - December 04, 2024

An FDA inspection of Calumet Karns City Refining, LLC, an API manufacturer in Karns City, PA, revealed significant deficiencies across multiple areas. The firm was cited for inadequate computer system controls, incomplete laboratory records, and poorly maintained facilities and equipment. Further observations included a failure of the quality unit to ensure CGMP compliance, insufficient stability testing, and inadequate documentation of nonconformance investigations, alongside issues with equipment cleaning validation, storage of rejected materials, and food storage in production areas.