Aurobindo Pharma unit gets FDA OAI classification
In short
Aurobindo Pharma’s US step-down subsidiary, Lannett Company LLC, got an Official Action Indicated classification from the US FDA after an August inspection found four observations. The company said it replied on time and that the action does not affect its finances or operations.
What the reporting says
Aurobindo Pharma’s step-down subsidiary Lannett Company LLC was classified as Official Action Indicated by the US FDA after an August inspection that found four observations. Aurobindo Pharma said it responded within the stipulated time and that the regulatory action has no impact on its financials or operations. The classification signals a regulatory issue for the US subsidiary, while the company says the business effect is nil for now.
Why it matters
The US FDA classified the inspection of Aurobindo Pharma’s step-down subsidiary Lannett Company LLC as Official Action Indicated after an August inspection produced four observations. Aurobindo Pharma said it replied within the required time and said the action has no impact on its financials or operations. The development is relevant to the company’s regulatory standing in the US.