Novartis plant's quality control understaffed, inadequately trained, FDA says

Novartis ($NVS) temporarily pulled the curtains on its Lincoln, NE, consumer drug plant in late December. What's been going on behind those windows? Pharmalot reports that, after a recent visit, FDA inspectors filed a 483 report on several manufacturing and quality control problems, including reporting failures and consumer complaints about rogue products in Novartis packages.

For instance, Excedrin migraine tablets were mixed up with Excedrin migraine caplets, and Novartis didn't fully investigate the problem batches, the report stated. The company concluded the problem wasn't within its control, Pharmalot reports, but the FDA says that's not plausible, because both drugs were packaged on the same line. What's more, Novartis didn't offer any evidence to support its conclusion the product mix-up stemmed from theft.

Indeed, the FDA said, none of the 223 "critical complaints" received were properly reviewed by Novartis. The company didn't have enough people assigned to probe the complaints, and those it did have weren't adequately trained. The plant wasn't likely to get more resources from corporate, either, given that higher-ups weren't alerted to some of the product mix-ups for two years.

Novartis can take heart from other product mix-ups that have plagued drugmakers of late. Mylan ($MYL) had to recall two drugs after labels for one were mistakenly applied to bottles of the other. Pfizer's ($PFE) Greenstone unit recalled bottles of its antidepressant citalopram because they might have contained the prostate drug finasteride. And Endo Pharmaceuticals ($ENDP) yanked two lots of its Endocet pain reliever after some higher-strength tablets were found mixed in with a lower-strength version.

- read the Pharmalot news

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