Aurobindo Pharma Under US FDA Scrutiny: Eight Observations Made

Aurobindo Pharma revealed that the US FDA issued a Form 483 with eight procedural observations following an inspection of its manufacturing facility in Telangana. The company plans to respond to the observations within the stipulated deadline. The inspection covered both oral solids and injectable units at the site.

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.)