Novartis warned over standards at generics sites
pharmafile | December 9, 2011 | News story | Manufacturing and Production |Â Â CGMP Failures, FDA compliance, Novartis, SandozÂ
The FDA has warned Novartis that three North American production facilities operated by its generics subsidiary Sandoz are failing to meet GMP standards.
The warning letter to chief executive Joe Jimenez follows inspections between May and August this year which uncovered a number of violations, including microbial contamination of sterile drug products. The FDA also criticises Novartis senior management for not working quickly enough to resolve the issues.
The plants cited in the letter include one in Canada at Boucherville, Quebec, and two US plants at Broomfield, Colorado, and Wilson, North Carolina.
The Boucherville site specialises in generic sterile injectable pharmaceuticals, with a portfolio of more than 100 products including narcotics, sedatives, antibiotics and ophthalmic agents.
It was pulled up for failing to establish and follow written procedures designed to prevent microbial contamination of sterile products (including validation of aseptic processing) and not following up batch failures properly. The site’s quality unit also relied on suppliers for some analyses – such as checking stoppers for endotoxin – rather than testing in-house.
The FDA letter – dated 18 November – notes that these are repeats of violations previously uncovered in a 2009 inspection.
Novartis is also taken to task for failing to submit a field alert report (FAR) within the proscribed time limit after customer complaints that could signal quality failures in products made at Boucherville, citing an example in which more than 30 consumers reports cloudiness in an injectable product.
Meanwhile, the Broomfield and Wilson facilities have been admonished for not having written procedures for production and process controls to ensure medicine quality, which is a repeat of an earlier warning letter sent in August 2008, and not investigating batch or component failures properly.
“Sandoz and Novartis are working closely with the [FDA] to ensure all observations regarding its US and Canadian production facilities are resolved to the agency’s full satisfaction,” said Novartis in a statement.
“We stand behind the safety and efficacy of our products, and are fully committed to maintaining high quality standards.”
Phil Taylor
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