FDA: Novartis plant shows patterns of problems

Health Canada on Friday advised Canadians that they should return certain Excedrin Extra Strength and Tension Headache caplets, just as drug giant Novartis ($NVS) advised U.S. consumers to do last week. According to a statement from Health Canada, the same issues underlie both recalls, and they resulted in chipped and broken pills and inconsistent package clearances, which could yield Excedrin bottles containing strays of other pills made at the plant.

It all stems from Novartis' troubled Lincoln, NE, plant, which the drugmaker voluntarily shut down in late December. Quick on the heels of the shutdown came the U.S. recalls and the announcement the company was working to strengthen "quality standards across all manufacturing sites."

Last summer, FDA inspectors visiting the Lincoln plant recorded an unlucky 13 observations in a Form 483 report. All relate to the first observation listed, in which investigators say the plant's QA unit "failed in the responsibility and authority to monitor Quality Systems designed to assure [sic] the quality of drug products." Among other observations is this one that was presented in boldfaced type: "You have failed to open deviation investigations into numerous 'critical' consumer complaints of foreign products found inside the drug products manufactured at your firm."

In fact, the bold type is scattered throughout the 13-page report. It shows up in another observation that concerns the company's failure to investigate all batches of a product that's found to have a problem. Here the regulator trumps the boldfaced type by also using all caps: "THIS IS A REPEAT DEVIATION FROM THE PREVIOUS INSPECTION AT YOUR SITE, DATED 4/5-16/10."

The FDA inspector notes several instances of deviations that occur multiple times, which he flags as "a pattern of problems at your firm."

- see the Health Canada statement
- and the Lincoln plant's Form 483 inspection report
- here's the U.S. recall information page