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.
When the FDA issued an import alert against Sun Pharma's plant in Gujarat in March, the drugmaker reassured investors the facility accounted for just 1% of U.S. sales. But with the allegations of failings at the plant becoming more and more damning, the FDA is reportedly following its now-familiar strategy of going after other facilities in the network.
The FDA sent a warning letter to Canton Laboratories in Vadodara, India, in February for a list of serious infractions, including falsifying data. The agency has taken the next step, issuing an import alert that bans products from the facility.