FDA 483 - Specialty Process Labs LLC - November 19, 2021

An FDA inspection of Specialty Process Labs, LLC in Phoenix, AZ, a manufacturer of thyroid Active Pharmaceutical Ingredient (API), revealed significant deficiencies across multiple systems. Observations included failures in computerized system controls, equipment qualification and maintenance, process and method validation, impurity profiling, and quality unit oversight. These issues indicate a lack of robust controls necessary to ensure product quality and data integrity.