Marksans Pharma gets 5 inspectional observations from USFDA for Goa facility
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Mumbai: Marksans Pharma has received 5 inspectional observations in Form 483 from the US Food and Drug Administration (USFDA) at the conclusion of the inspection at its manufacturing facility located in Verna, Goa, India.
The inspection was conducted from 9th April 2024 to 17th April 2024.
"This is to inform you that a routine current Good Manufacturing Practices (cGMP) inspection was conducted by the USFDA at the manufacturing facility of the Company located in Verna, Goa, India from 9th April 2024 to 17th April 2024," the Company informed in a BSE filing.
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.
"There is no data integrity observation. The Company will work closely with the USFDA and is committed to address these observations comprehensively within the stipulated time," Marksans stated.
Medical Dialogues team had earlier stated that the Company's newly acquired Goa manufacturing facility had successfully undergone inspection from German health authorities.
Marksans Pharma Ltd headquartered in Mumbai, India is engaged in the Research, Manufacturing & Marketing of generic pharmaceutical formulations in the global markets. The company's manufacturing facilities are approved by several leading regulatory agencies including USFDA, UKMHRA, and Australian TGA. The company's product portfolio spreads over major therapeutic segments of CVS, CNS, Antidiabetic, Pain Management, Gastroenterological, and Anti-allergies. The company is marketing these products globally.
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