WHO warns on Sandoz' SA plant

After an inspection that showed up more than 40 faults, the World Health Organization warned customers not to buy drugs made by Swiss drug major Novartis' Sandoz generics manufacturing facility in South Africa.

The WHO said it had sent an official Notice of Concern letter to Sandoz on September 12 after an inspection of the unit's Kempton Park factory in South Africa, which revealed 41 separate cases classified as non-compliances and deviations from WHO Good Manufacturing Practices. For example, the firm failed to ensure that, where starting and primary packaging materials and intermediate or bulk products were exposed to the environment, interior surfaces were not smooth and free from cracks and open joints, and did not permit easy and effective cleaning and, if necessary, disinfection, the WHO said.

For its part, Sandoz has said it is working to resolve the problems at the plant, which mainly produces combinalosis and widely sold in developing countries, and hopes to schedule a re-visit from WHO officials.