Piramal Pharma Ltd on Wednesday (February 7) said its Riverview facility in the United States underwent the scrutiny of the US Food and Drug Administration (FDA) during a pre-approval inspection (PAI) conducted from January 29 to February 6, 2024.
Following the inspection, the FDA issued a Form 483, highlighting three observations.
"This is to inform you that the US FDA conducted a Pre-Approval Inspection (PAI) inspection of Piramal Pharma Limited's Riverview (USA) facility from 29th January 2024 to 6th February 2024," the company said in a regulatory filing,
Despite the regulatory scrutiny, Piramal Pharma assured stakeholders that the observations were categorised under the Voluntary Action Indicated (VAI) category and did not pertain to data integrity.
"On conclusion of the inspection, a Form 483 was issued with 3 observations. The observations were classified under VAI (Voluntary Action Indicated) and do not relate to data integrity," it said.
The company emphasised its commitment to upholding the highest standards of compliance and affirmed its dedication to working closely with the FDA to address the identified observations.
"The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations," it added.
The Form 483 observations serve as a regulatory mechanism for the FDA to communicate concerns regarding compliance with good manufacturing practices (GMP) at pharmaceutical facilities.
However, the classification under VAI indicates that the FDA recognises the willingness of Piramal Pharma to take proactive measures to rectify any deficiencies.
Shares of Piramal Pharma Ltd ended at ₹139.25, down by ₹1.65, or 1.17%, on the BSE.
