USA – Indian drugmaker gets warning letter from FDA

The US Food and Drug Administration (FDA) hit Indian drugmaker Aurobindo with a warning letter for inadequately investigating batch failures related to its manufacturing of active pharmaceutical ingredients (APIs) and for failing to evaluate the potential effect of changes on its intermediates and APIs.

The firm was warned for “significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients.”

The company’s Telanga, Hyderabad site was handed the warning letter following an August 2021 inspection. It was issued on 12 January 2022 and posted to FDA’s website on earlier this week.

The firm was targeted for failing to evaluate the effect of changes on the quality of drug intermediates and APIs. For example, the company increased acceptance limits for starting materials without evaluating the effect of this increase on the quality of drug intermediates and the APIs…