India's Wockhardt, already trying to get out from under an FDA warning letter for two key plants, has come up short in its effort to get the agency to approve a new sterile injectables facility.
A Chinese drugmaker that has a joint venture with Pfizer to produce generic drugs and plans to separately make biosimilars has been savaged by the FDA in a warning letter for serious data manipulation and shipping to the U.S. products that repeatedly failed follow-up testing by customers.
Since its key plant in Halol was written up by the FDA following an inspection last year, Sun Pharmaceutical has gone all out to get on top of the agency's concerns. It has brought in outside consultants and invested in new systems and employee training. But it wasn't enough to ward off an FDA warning letter.
Mylan recently got hammered by the FDA in a warning letter for three plants that it acquired as part of its $1.75 billion acquisition of the sterile injectables business of what was then Strides Arcolabs. Now Mylan is apparently looking for Strides to cough up some of the cost of getting those plants back into shape.
The FDA has cited a Novacyl active pharmaceutical ingredient (API) manufacturing plant in Thailand with a warning letter after finding some of the same issues there that it had uncovered at the company's facility in China.
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.
The FDA has found problems at the Mexican plant where Anascorp, the only scorpion antivenom available in the U.S., is manufactured, listing more than a dozen observations in a recent warning letter.
The steady string of warning letters issued to Indian drug and ingredient makers as the FDA has added to its staff in India is fueling the perception that the country has issues when it comes to quality. Now another warning letter has been issued.
Last year, FDA inspectors said employees at the Canton Laboratories active pharmaceutical ingredient facility in Vadodara, India, were not getting equipment clean enough between batches to prevent cross contamination. The company's certificates of analysis had been showing that its APIs were within limits for microbial and metal content, but there was a problem with those tests: They never occurred.