A Fresenius Kabi sterile manufacturing plant in New York that the FDA cited in 2012 after finding insects in some of the drug vials has earned a reprieve from the agency. The drugmaker said Tuesday that the FDA will allow the APP Pharmaceuticals plant to seek approvals for drugs manufactured there.
The Germany-based drugmaker announced Tuesday that the FDA has upgraded the status of the facility to voluntary action indicated (VAI) from the previous designation of official action indicated, the company said. The new status came after an inspection in October.
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