Mumbai: Piramal Pharma has announced that the company has received four observations from the U.S. Food and Drug Administration (USFDA) for Lexington (Kentucky, USA) facility.
The general Good Manufacturing Practices (GMP) inspection of the facility was held from 3rd December, 2025 to 10th December, 2025.
At the conclusion of the inspection, the US FDA issued a Form-483, with four observations.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
These observations are related to enhancement in procedures and will be classified as a voluntary action indicated (VAI). VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
“The Company is preparing a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines,”
Piramal Pharma said in a BSE filing.
“The Company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations,” the company added.
Piramal Pharma Limited (PPL) offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 15 global facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business, and the India Consumer Healthcare business selling over-the-counter products.
PPS offers end-to-end development and manufacturing solutions through a globally integrated network of facilities across the drug life cycle to innovators and generic companies. PCC’s complex hospital product portfolio includes inhalation anaesthetics, intrathecal therapies for spasticity and pain management, injectable pain and anaesthetics, injectable anti-infectives, and other therapies.
