Mumbai, Sept. 8 -- The inspection, covering both oral solids and injectable units, was conducted between 25 August and 5 September 2025. At the conclusion, the USFDA issued a Form 483 citing eight procedural observations.

The company clarified that the observations are procedural in nature and do not affect its financials or operations. Aurobindo added that it will submit a detailed response to the USFDA within the stipulated timelines.

"The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe," it said.

Aurobindo Pharma is principally engaged in the manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals, and related services.

The c...