Manufacturing Round-Up: FDA Demands Meeting With Aurobindo Over Issues At Multiple Sites

An FDA warning letter issued to Aurobindo highlights recurring failures over several sites, while Teva is setting up a biologics development campus in the US and Nexus is investing in sterile injectables capacity.

Work station
Compliance problems continue to haunt Aurobindo's API facilities • Source: Shutterstock

Aurobindo Pharma has been told to schedule a regulatory meeting with the US Food and Drug Administration to discuss current good manufacturing practice compliance problems at three of its bulk drugs facilities.

Giving the Indian producer five days to arrange a meeting over the firm’s Unit XI, I and IX active pharmaceutical ingredient plants, the FDA points out in a warning letter over the Unit XI plant that it had identified similar issues at

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