USFDA inspection: Piramal Pharma gets Form 483 with 6 observations for Lexington facility
The observations were classified under VAI (Voluntary Action Indicated) and does not relate to data integrity.
Mumbai: Piramal Pharma has recently announced that the US Food and Drug Administration (USFDA) has issued a Form-483, with six observations at the conclusion of the inspection at the company's facility located at Lexington (Kentucky, USA).
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.
USFDA conducted a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection of Piramal Pharma Limited's Lexington facility from 27th December 2022 to 10th January, 2023.
The observations were classified under VAI (Voluntary Action Indicated) and does not relate to data integrity.
"The Company is preparing a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines," Piramal stated 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," Piramal Pharma further stated.
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