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US FDA Poses Next-Level GMP Challenges For Aurobindo's Polepally Site

 
• By Bowman Cox

Agency conducts follow-up inspection as Aurobindo's Polepally, India, manufacturing facility looks to move on from crippling OAI designation.

broken tablet
aurobindo may be putting it together again at polepally • Source: Shutterstock

A 2-10 May 2022 inspection by the US Food and Drug Administration of Aurobindo Pharma Limited's Polepally, India, plant challenged the manufacturer to further improve quality at the site, which the FDA had classified as “official action indicated” based on an inspection that ended 27 September 2019.

The OAI inspection result came after a series of no-action-indicated inspections in 2012-2017, according to the FDA’s site inspection classification database

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