FDA scolds Novartis unit for repeat plant violations

FDA warning letters are continuing to pile up. This time, it's no small fry under the manufacturing microscope, but the Swiss drugmaker Novartis ($NVS) and its generics unit Sandoz. Three North American plants--in Quebec, North Carolina, and Colorado--fell short in recent inspections, the agency says. And the company's response to inspectors' concerns fell short, too.

The violations? In Quebec, batches of an injectable drug had to be tossed out because of crystallization problems, and staffers didn't investigate thoroughly, the letter states. In fact, the crystallization happened so frequently, the agency is "concerned that your firm lacks process understanding to consistently manufacture" that injectable drug, the letter states. In Colorado, inspectors found repeated instances of inadequate equipment cleaning, despite promises to fix the problem. In North Carolina, process validation for several products was deemed inadequate.

Toward the end, the FDA's letter got a bit indignant, citing "multiple repeated violations" and a lack of "global and sustainable corrective actions." And the agency took aim not only at the individual plants, but higher-ups at Sandoz--and even higher, at Novartis. "[T]he Agency is concerned about the response of Novartis to this matter," the letter states. "Corporate management has the responsibility to ensure the quality, safety, and integrity of its products. Neither upper management at Novartis nor at Sandoz Inc., nor at Sandoz Canada Inc., ensured global, adequate, or timely resolution of the issues at these sites."

The FDA is threatening to keep products from the Canadian site out of the U.S. if the company doesn't come into compliance, and to withhold approval of any new products "listing your firm as a drug product manufacturer." And if the U.S. facilities don't fall into line, the letter says, the FDA could go so far as to seize products.

The company says it and its Sandoz unit are working with the agency to resolve the problems cited in the warning letter, MarketWatch reports. "We stand behind the safety and efficacy of our products, and are fully committed to maintaining high quality standards for both our products and manufacturing sites in the U.S., Canada and around the world," Novartis said.

- read the FDA letter
- get more from Reuters
- check out the MarketWatch story

Special Report: Fierce's 2011 warning letters report