FDA notes lack of Novartis exec response in 3-site warning

Novartis ($NVS) CEO Joe Jimenez (photo) was on the receiving end of a particularly pointed FDA warning letter last month concerning generics unit Sandoz, and the letter made its way to the agency's website Tuesday. Of note, the letter mentions the FDA's concern about the company's response to cited manufacturing violations, several of which are repeats.

"Corporate management has the responsibility to ensure the quality, safety, and integrity of its products. Neither upper management at Novartis nor at Sandoz ... ensured global, adequate, or timely resolution of the issues."

Novartis said in an emailed statement the citations in the warning "primarily relate to general documentation, validation and investigation practices." The companies are "working closely with the FDA" and are "fully committed to promptly addressing the observations."

The warning covers GMP violations at three Sandoz facilities in North America, stemming from April/May, June and July/August inspections. The company supplied responses to the FDA Form 483 inspection reports in May, July and August.

Among violations at the Sandoz Canada site in Quebec: Failure to file field alert reports within the requisite three days of discovering contamination or deterioration in distributed products. The FDA directs the company to develop the necessary procedures and provide employee training. "We will verify the implementation and effectiveness of this corrective action during a future inspection," the letter states.

The warning also mentions a repeat violation concerning the failure of media fill studies to demonstrate in-control aseptic production. The letter includes 5 examples stretching back to August 2009.

Two of the three Sandoz sites were cited for repeat GMP violations. At the Broomfield, CO, plant, inspectors found inadequate written procedures for ensuring that manufactured products meet specifications. Nearly 20% of lab investigations for batch or component failures, the letter said, included no documentation showing that the company checked associated batches or implemented corrective actions.

The FDA had previously cited this violation in a 2008 warning letter directed at a Sandoz plant in North Carolina. Its mention among citations at the Broomfield plant shows the agency's view that the company needs to have an overall GMP program, rather than programs at each site.

"It is apparent that Novartis ... is not implementing global and sustainable corrective actions. FDA expects Novartis to undertake a comprehensive and global assessment of your manufacturing operations to ensure that drug products conform to FDA requirements," the letter says.

Novartis said it's committed to "assuring the FDA that all ... corrections are being applied systematically to the Novartis and Sandoz network of manufacturing sites," according to the statement.

- here's Warning Letter 320-12-05
- see the WSJ digital network story

Special Report: Fierce's 2011 warning letters report

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