The QMN Weekly Bulletin

The World Health Organization (WHO) cited a South African manufacturing plant owned by Novartis subsidiary Sandoz in the first “notice of concern” letter the UN body has publicly disseminated.

The agency is recommending that public health agencies such as the President’s Emergency Plan for AIDS Relief and The United Nation’s Childrens Fund (UNICEF) stop buying drugs made at the plant, and it plans to refer the matter to the Medicines Control Council of South Africa.

The WHO’s letter comes one month after the FDA cited Sandoz’s Wilson, N.C., facility for various GMP deficiencies, including inadequate validation of the production process for generic Toprol XL (metoprolol succinate).

During a May inspection of Sandoz’s facility in Kempton Park, South Africa, 41 manufacturing observations were noted, the WHO letter says. The inspection was carried out under an agency program to prequalify medicines.

The prequalification program publishes a list of sites that manufacture reproductive health drugs and drugs to treat HIV/AIDS, malaria and tuberculosis that may be sold to UN agencies UNAIDS and UNICEF.