Manufacturing snafus at a plant in South Africa have put some Novartis generic products in jeopardy. The World Health Organization is considering revoking its OK for Sandoz, the Swiss drugmaker's generics arm, to sell some of the antibiotics made at that facility.
The Financial Times reports that officials are poised to tell customers to stop buying products made at a Sandoz plant in Kempton Park, Gauteng, South Africa. That's because of 41 "non-compliances and deviations" from good manufacturing practice found so far this year. The factory makes meds that treat tuberculosis, using combinations of the antibiotic rifampicin.
The WHO found lapses at the plant in May, including failure to prevent contamination of surfaces there. The inspectors wanted to make a follow-up visit in August to make sure the problems had been fixed, but Sandoz told them they could not visit again this year. Under threat of losing its authorization for the plant, Sandoz said it would find an earlier date for the inspection team to visit, even if some of the corrective actions aren't yet complete. The company says it's committed to completing the spruce-up by the first quarter next year.
- read the Financial Times story