Piramal Pharma's Lexington manufacturing facility in the US was slapped with a Form-483 by the US Food and Drug Administration (US FDA).

The observations came after the US FDA conducted a pre-approval inspection (PAI) and good manufacturing practices (GMP) inspection of Piramal Pharma’s Lexington facility located in Kentucky, USA, from December 27, 2022 to January 10, 2023.

Piramal Pharma said, “After the inspection, the USFDA issued a Form-483 with six observations. The observations were classified under VAI (Voluntary Action Indicated) and do not relate to data integrity.”

Piramal Pharma said that the company is preparing a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines.