Umicore Argentina S.A. – FDA 483

Unicore Argentina S.A., an API manufacturer in Pilar, Buenos Aires, was cited for significant quality system failures during an FDA inspection. Observations included inadequate investigations for out-of-specification results and complaints, deficiencies in process validation, and poor facility and equipment maintenance. Additionally, the firm demonstrated ineffective control of water systems, pest control, and routinely used materials prior to quality control approval or after expiration.