Piramal Pharma Receives Form 483 from USFDA for Lexington Facility with 2 Observations

26 Feb 2024 , 11:37 AM

From February 20 to 23, 2024, the US FDA performed a Pre-Approval Inspection (PAI) at Piramal Pharma Limited’s Lexington, USA, plant in order to examine one of the products that is anticipated to be produced there.

A Form-483 with two observations was issued following the examination. The site’s business continuity or compliance with compliance standards are not at risk as a result of the observations. The Company is getting ready to submit to the US FDA within the allotted timeframe a comprehensive response to the aforementioned observations.

The Company is still dedicated to upholding the highest compliance standards, and it will collaborate closely with the agency to thoroughly address each and every observation.

Piramal Pharma Limited’s shares traded at ₹135.50 down 0.60% from previous close of ₹136.30.

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