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.
The Economic Times reports that it has seen the Form 483 issued to one of Sun's Gujarat, India, plants after an inspection last month. It said that the FDA criticized Sun for not implementing "all the [corrective] actions" it should have when recalling the metformin, as well as following the recall of its version of the anxiety drug venlafaxine hydrochloride extended release tablets, even though it had insisted to the FDA that it had. In July, the plant had to recall 26,530 bottles of the generic of Pfizer's ($PFE) Effexor XR because the tablets did not dissolve properly.
The Form 483 had 23 observations, the newspaper reports. Other concerns included the fact that the plant allowed multiple users to access the same piece of testing equipment with a common password, a concern because if data is deleted or manipulated, there is no way of determining by whom. There also were concerns about the general maintenance, the Economic Times reports.
The plant in question is not the same facility in Gujarat that the FDA put on its import alert list in March. A warning letter for that plant issued in May slammed it for suspect drug testing, among other issues. The company declined to comment to the newspaper about the FDA concerns laid out in Form 483.
The regulatory action comes only weeks before Sun is slated to close on its $4 billion, all-stock deal to buy Ranbaxy Laboratories, India's largest domestic drugmaker, and one that has had years of serious regulatory problems with the FDA. When announcing the deal in April, Sun officials insisted the company was well positioned to get Ranbaxy's quality issues resolved with the FDA.
- read the Economic Times story