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Marksans Pharma’s Goa unit receives Form 483 from USFDA with five inspectional observations, reports ET HealthWorld

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USFDA issues Form 483 with five inspectional observations to Marksans Pharma's Goa unit, ET HealthWorld

The US health regulator has issued a Form 483 with five inspectional observations to Marksans Pharma Ltd after inspecting its manufacturing facility in Goa, India. The US Food and Drug Administration (USFDA) conducted a routine current Good Manufacturing Practices (cGMP) inspection at the facility from April 9-17, 2024.

Form 483 is issued by the USFDA at the conclusion of an inspection when conditions that may violate the Food Drug and Cosmetic (FD&C) Act and related Acts are observed. Marksans Pharma received five such observations but no data integrity issues were reported.

The company has stated that it will work closely with the USFDA to address the observations comprehensively within the stipulated time. The specifics of the observations have not been disclosed as of yet. The company remains committed to maintaining high standards of quality and compliance in its manufacturing processes.

This development underscores the importance of regulatory compliance in the pharmaceutical industry. Companies must adhere to stringent guidelines set by regulatory authorities to ensure the safety and efficacy of their products. Marksans Pharma’s response to the Form 483 observations will be closely monitored by stakeholders and regulatory bodies alike to assess their commitment to quality assurance.

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