The Saudi Food and Drug Authority suspended a European pharma factory due to serious GMP violations, ensuring pharmaceutical safety for Saudi Arabia.
In a decisive move to uphold pharmaceutical safety, the Saudi Food and Drug Authority (SFDA) has suspended the registration of a European pharmaceutical factory. This suspension follows the uncovering of significant violations of Good Manufacturing Practices (GMP) during a rigorous external inspection.
This action was taken after SFDA inspectors found critical deficiencies in the factory's manufacturing processes and internal quality control systems. Such lapses posed an immediate threat to the safety of pharmaceutical products destined for the Saudi market.
The suspension serves as a preventive step to ensure that potentially unsafe medicines do not reach consumers in the Kingdom. Conducted as part of the SFDA’s foreign factory oversight initiative, the inspection was aligned with global regulatory standards, thoroughly examining the facility's operations, quality control measures, and distribution practices.
The incident has drawn the attention of several European regulatory bodies, which have contacted the SFDA to review the technical findings and consider further measures. This interaction underscores the SFDA’s growing international influence in pharmaceutical regulation.
The SFDA emphasized that monitoring foreign manufacturing sites remains a cornerstone of its regulatory strategy, employing independent scientific and technical evaluations.
The Authority reiterated its ongoing commitment to consumer safety, vowing to enforce strict compliance and take firm action against any manufacturers that jeopardize safety standards.
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