Mumbai, April 13 -- In a regulatory filing made in December last year, the company said that the United States Food and Drug Administration (US FDA) conducted a general good manufacturing practices (GMP) inspection of Piramal Pharma's Lexington (Kentucky, USA) facility from 03 December 2025 to 10 December 2025.

At the conclusion of the inspection, the US FDA issued a Form-483, with four observations.

"These observations are related to enhancement in procedures and will be classified as a VAI (voluntary action indicated). The company is preparing a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines," Piramal Pharma had said in a statement.

Offering updates on the same, Piramal Ph...