FDA Gives Biocon Biologics OAI Classification

In the latest FDA blow to Biocon Biologics, a July inspection of its insulin production facility in Johor, Malaysia, has been classified by the agency as “Official Action Indicated” (OAI), the most serious inspection classification and one step short of a warning letter or other enforcement action.

In an Oct. 18 statement, Biocon said it has submitted a comprehensive corrective and preventive action plan to the FDA in response to observations from the July inspection, which cited the facility for numerous problems, including sterility issues, inadequate deviation investigations and poor testing procedures on the drug side of the operation and inadequate risk analysis in its device manufacturing.

The company says it is “on track to complete all actions as committed” following the inspection, adding that the company will continue to engage with the agency “to understand any outstanding concerns and work closely to address them expeditiously.”

Read the untitled letter to Nectar here.

To read the whole story, click here to subscribe.

Related Topics