FDA 483 - Sterling Pharmaceutical Services LLC - April 06, 2018

Sterling Pharmaceutical Services, LLC in Dupo, IL, was cited for significant deficiencies across its manufacturing operations, including a lack of written production and process controls, inadequate laboratory controls, and deficient complaint handling procedures. The inspection revealed issues with process validation, OOS investigations, analytical method validation, reserve sample management, and the failure to record and justify deviations from established procedures. These findings indicate a systemic breakdown in ensuring drug product quality, strength, and purity.