FDA warning letter for two Sandoz plants in India
The sites are understood to be those in Turbhe and Kalwa, India, which were inspected in August last year. Novartis previously announced plans to close the Turbhe plant but Jiminez said the Kalwa site will remain open:
“If you remember, last year, we told you that we had one bad exception – an inspection at our Indian sites […] we began remediating immediately. There were two sites, one of them we’ve decided to close; we’ve remediated the other.
“We did however receive a warning letter from the FDA yesterday, so it will be posted. But a lot of the remediation has already taken place because it was over a year ago.”
The Turbhe site produces APIs and antibiotics while Kalwa makes oral solid dosages. The CEO said the warning letter had not affected supply of its drugs.
The FDA had not posted the warning letter on its site at the time of publication.
"Sandoz will continue to work closely with the FDA to ensure all observations are resolved to the agency's full satisfaction," the company told Reuters.
