When India's Cadila Pharmaceuticals got complaints from customers about some of its APIs smelling bad, the drugmaker decided the odor stemmed from an impurity, so it tweaked the manufacturing process. The problem, according to the FDA, is that the plant never conducted an investigation to determine whether the impurity was in fact the cause, so the company never knew whether it had really resolved the cause of the stench.
Hikma recently acknowledged that it had received a warning letter from the FDA for a plant in Portugal. What the drugmaker did not disclose is that some of the warnings were repeats, noted in three previous inspections of the facility dating back a decade.
Hikma Pharmaceuticals got a closeout notice in March for a warning letter that had been hanging over its West-Ward plant in New Jersey. But at nearly the same time, inspectors were looking over a Hikma facility in Portugal, and the Jordan-based company says the FDA has now issued a warning letter for its sterile injectables plant there.
A Sanofi spokesperson told The Wall Street Journal that it has delayed some forms of its Fluzone because the flu strains used to produce the shot did not grow as fast as expected. A GSK spokesman said in an email Monday that it has cut its production targets to 26 million to 27 million doses for the U.S. from the 28 million to 33 million doses originally anticipated.
The FDA, which has been corralling human drug compounders, is also keeping track of some focused on animal drugs.
The FDA has taken steps against a Chinese heparin maker it says is using potentially tainted raw supplies and which refused to let inspectors get a good look at its plants or records so that it could find out for sure.
In March, Sun Pharmaceutical recalled more than 2,500 bottles of its diabetes treatment metformin HCl after a customer reported finding an epilepsy pill in one. The company said it was investigating the issue, but apparently not to the satisfaction of the FDA.
Hospira has been dealing with FDA concerns for years for plants in the U.S. and more recently in India. But despite being told more than a year ago that it should have a "global corrective action plan" for both its foreign and U.S. plants, new issues have surfaced, this time for a plant in Australia that makes specialty injectable drugs.
Thinking it needs to change the spin on the story, an industry group in India has hired a Washington, D.C., consulting firm which is launching a campaign it hopes can do that.
On Tuesday, the FDA posted a warning letter sent last week to Chinese ingredientmaker Tianjin Zhongan Pharmaceutical listing problems with keeping equipment clean and running down problems.