A Novartis AG manufacturing plant in Broomfield was among three cited by the U.S. Food and Drug Administration for violations of good manufacturing practices, according to a letter posted on the agency’s website.
The plants based in Broomfield; Wilson, N.C.; and Boucherville, Quebec, make products for the Basel, Switzerland-based company’s Sandoz generic-drug unit.
The FDA’s citations mainly related to documentation, validation and investigation practices, Novartis said today in an e-mailed statement.
“Sandoz and Novartis are working closely with the U.S. Food and Drug Administration to ensure all observations regarding its U.S. and Canadian production facilities are resolved to the agency’s full satisfaction,” Novartis said. “We stand behind the safety and efficacy of our products, and are fully committed to maintaining high quality standards.”
