Sandoz, the Novartis generic unit, may lose World Health Organization authorization to sell some antibiotics after regulators identified manufacturing problems at a South African factory, The Financial Times reports.

The WHO plans to tell customers to stop buying products made at a Sandoz plant in Kempton Park, Gauteng, after finding 41 “non-compliances and deviations” from good manufacturing practices. The FT notes the lapses are “an embarrassment for Novartis, which has expanded its generic business and prides itself on developing treatments for illnesses such as malaria for the developing world.”

The WHO, which runs a “pre-qualification” quality approval program used by developing countries, identified last May such problems as a failure to prevent contamination or to ensure easy cleaning of surfaces in its plants. The factory makes meds using combinations of rifampicin, an antibiotic used to treat tuberculosis that is widely used in developing countries, the FT writes.

After the WHO inspectors identified a series of problems, they proposed a follow-up audit in August to ensure that remedial actions had been taken but were told by Sandoz they would not be able to visit again this year. [Our thought: what a fabulous way to make a good impression].

The WHO plans to suspend the plant’s drugs from its list of prequalified meds and refuse applications to authorize other meds made at the factory, and also recommended customers stop buying drugs made there. However, Sandoz tells the FT it is willing to find “an earlier date that is suitable for the inspection team, even if some of the corrective actions will not be complete at that time.”

“The WHO concerns focus mainly on ongoing maintenance issues and controls of existing policies and procedures. Sandoz is committed to completing these changes by Q1 2009, partly to accommodate the longer-term actions recommended by the WHO,” according to a statement given the FT.