Aurobindo Pharma Under US FDA Scrutiny: Eight Observations Made

Aurobindo Pharma announced on Friday that the US Food and Drug Administration (FDA) has issued a Form 483 containing eight observations after conducting an inspection of its Telangana-based manufacturing facility.

The inspection, which took place from August 25 to September 5 at the company's Unit-XII in Bachupally, involved examining both oral solids and injectable manufacturing units, according to the Hyderabad-based pharmaceutical company's regulatory filing.

At the conclusion of the inspection, the US FDA issued a Form 483, highlighting eight procedural observations. Aurobindo Pharma confirmed that it will address the FDA's findings within the required timeframe.

(With inputs from agencies.)