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.
According to a warning letter sent Feb. 28 and posted this week on the FDA website, Total Pharmacy Services has been making domperidone, a drug some breastfeeding women take to boost lactation.
The European Medicines Agency is now making public its reports on companies that have failed plant inspections. The FDA has made warning letters and some Form 483 reports public for some years, but the EMA had not, according to Pharmafile, which went through the nearly 7 dozen reports in the data base that date back to 2007.