SFDA suspends European pharmaceutical factory over critical GMP violations
RIYADH — The Saudi Food and Drug Authority (SFDA) has suspended the registration of a European pharmaceutical factory following the discovery of serious violations of Good Manufacturing Practices (GMP) during an external inspection.
The decision came after SFDA inspectors identified fundamental lapses in the factory's manufacturing procedures and internal quality systems, posing a direct risk to the safety of pharmaceutical products intended for export to Saudi Arabia.
The suspension was enacted as a precautionary measure to prevent the distribution of potentially unsafe medicines in the Kingdom.
The inspection, conducted under the SFDA's foreign factory oversight program, aligns with international regulatory standards and involved a comprehensive review of the facility's manufacturing operations, quality controls, and distribution protocols.
Several European regulatory agencies have since reached out to the SFDA to examine its technical findings and take further actions, reflecting growing international recognition of the SFDA's regulatory rigor and global role in pharmaceutical safety.
The Authority stressed that the monitoring of overseas manufacturing sites is a key pillar of its regulatory framework and is carried out independently using scientific and technical data.
It reaffirmed its commitment to consumer safety and pledged to continue taking decisive action against any manufacturer found to be in violation of safety protocols.
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