SFDA Conducts Field Visits to 197 Pharmaceutical, Medical Device Factories in 2023

Saudi Food and Drug Authority (SFDA) inspectors made 1,713 observations during their visits to 113 pharmaceutical factories in 2023. The visits aimed to ensure that the factories met satisfactory manufacturing criteria before selling products in local markets, ensuring medicine's safety in the Kingdom of Saudi Arabia.
Foreign factories comprised 74% of the visits, with 84 factories, while 29 local factories were also inspected. Of these, 102 were human pharmaceutical factories, and 11 were veterinary medicine factories. Inspectors suspended ten of the visited factories.
The inspectors also visited medical device factories and noted 655 cases of non-conformity during 84 visits. Of these, 50 cases were from local and 34 from foreign factories. As a result, the inspection teams halted production at a local factory, suspended three foreign factories, fined eight, issued warnings to three, and seized three million products from local factories.
Furthermore, inspectors visited 18 conformity assessment bodies for food, cosmetics, and medical devices. During these visits, they suspended three bodies after conducting further assessments and recorded 47 violations. Of these, 24 were related to SFDA requirements, 18 to "ISO 17065" criteria, and two to "ISO 17021" criteria.