Novartis expects to resume shipping drugs made at its Nebraska, US plant by the end of the year and is on track to fix other quality issues at Sandoz sites hits with 483s in 2011.
In a memo published last week ,CEO Joseph Jimenez confirmed that Novartis has started producing Excedrin at the Lincoln, Nebraska plant that received a warning letter from the Food and Drug Administration (FDA) earlier this year .
He said that: “Upon successful validation, we expect to begin shipping a limited portfolio of products from Lincoln in the fourth quarter.”
Jimenez also said the firm is making progress resolving problems” at facilities operated by Novartis generics unit Sandoz that were also criticised by the FDA last year , citing the new management teams hired at the plants in question as an example of the work done to date.
Jimenez also outlined an new quality initiative the firm has launched, which includes five key behaviors that he said must be "an even more visible part of [Novartis'] culture:
- Think quality always
- Speak up for quality
- jointly own problems
- Always ask why
- build skills
"I want our customers and regulators to know that each person at Novartis takes personal responsibility for quality," adding that "When you see something that's not right, tell your colleagues, your managers or me."