FDA not satisfied with Cadila's efforts to fix warfarin production, even after 15 responses

Cadila Healthcare last week got out in front of bad news by announcing it had received a warning letter from the FDA for two of its Indian plants but was doing all that was asked by the agency. What it didn't explain in the announcement is that it had yet to satisfy the FDA even after responding 15 times to FDA concerns, or that the FDA was particularly troubled by its manufacturing of the blood thinner warfarin.

Cadila, the latest Indian drugmaker to be slapped with a warning missive, was cited for problems at its Moraiya formulation facility as well as its Zyfine API plant in Ahmedabad. Top of the FDA's list of concerns was its failure to identify the reasons why some of it warfarin products didn't live up to standards. There were at least 5 batches that fell short of expectations.

The problems were bad enough that the plant even stopped producing the drug for several months to get on top of them. But what really ticked the FDA off is that it after it restarted production, claiming all was well, there were more incidents of tablets failing tests. The FDA said in its most recent inspection the problems still continue.

On top of that, the company was cited for failing to investigate pharmacy complaints that some bottles contained mixed-up products. Like many other Indian drugmakers who have gotten crosswise with the FDA, Cadila wasn't protecting its computers with passwords to prevent data on testing from being destroyed.

Of course, Cadila's two Indian plants joins a long list of facilities in that country that have been criticized by the FDA for not living up to expectations. The citation follows warnings last year to some of India's drugmakers, including Sun Pharmaceutical and Dr. Reddy's Laboratories ($RDY) but also to Mylan's ($MYL) for problems at sterile injectable operations it has in India.

- here's the warning letter

Read more on