The FDA has issued Andrx a new Form 483 after a reinspection of the drugmaker's Florida manufacturing plant, according to documents filed with the Securities and Exchange Commission (SEC).
Andrx said it would respond "promptly" to the observations the FDA made after its reinspection of Andrx's plant in March.
The FDA issued a Form 483 to Andrx in September 2005 after the agency found manufacturing violations at the drugmaker's Florida plant. The agency's Florida office then placed Andrx on Official Action Indicated status. As a consequence, all of Andrx's pending drug applications have been placed on hold.
"Resolution of the company's current Official Action Indicated (OAI) status is primarily dependent upon the FDA's review of the results of the inspection, which includes, among other things, the company's response to the observations," Andrx said in the SEC filing.