Aurobindo Pharma subsidiary gets one observation during a US FDA inspection of the Tirupati plant

APL Healthcare Limited, a subsidiary of Aurobindo Pharma, has received a 'Form 483' with one observation from the US Food and Drug Administration for its Unit IV factory in Tirupati District, Andhra Pradesh, the company informed stock exchanges on September 20.

 

The inspection took place from September 13 to September 19, 2023.

 

The company stated in a press statement that the 'Form 483', which was issued with one observation, is of a procedural nature. When the US FDA observes any lapses during a facility inspection, it issues a Form 483. The companies are then directed to establish corrective action plans to address the issues.

 

According to analysts, the least important concern for companies is procedural observation. Quality or data integrity issues are of greater concern and can result in significant regulatory action.

 

Aurobindo Pharma stated that it will respond to the US FDA within the timeframes specified and will work closely with the US FDA to close the observation as soon as possible.

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