Topic:

Warning Letters

Latest Headlines

Latest Headlines

Hikma gets FDA warning letter for plant in Portugal

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.

Production issues for GSK, Sanofi delay flu vaccines in the U.S.

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.

FDA cites animal drug compounder for selling copies of Novartis' Capstar

The FDA, which has been corralling human drug compounders, is also keeping track of some focused on animal drugs.

FDA bans maker of suspect Chinese heparin

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.

FDA chastises Sun for weak follow-through on drug recalls

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.

New FDA concerns arise for Hospira plant in Australia

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.

India's IPA hires consulting firm to help it overcome bad publicity

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.

FDA finds fault with Chinese API maker

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.

Report: FDA to inspect more Sun plants in the next few weeks

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.

FDA tags yet another Indian drugmaker, Canton Labs, with ban

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.