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Marksans Pharma gets 8 USFDA observations for its Goa facility


Marksans Pharma gets 8 USFDA observations for its Goa facility

Though Marksans did not provide any details about the observations, it said that none of these observations is considered either critical or repetitive in nature.

New Delhi: Drug firm Marksans Pharma Thursday said it has received eight observations from the US health regulator after the inspection of its Goa facility. The United States Food and Drug Administration (USFDA) has concluded inspection of company’s Goa plant, Marksans Pharma said in a filing to BSE.

“The inspection of the facility took place between February 25 to March 6, 2019, resulting in a Form 483 with eight observations,” it added.

The FDA Form 483 is officially called a “Notice of Inspectional Observations,” commonly referred to simply as a “483.” The 483 is issued at the end of an on-site inspection if the FDA field investigator observed deficiencies in your quality system or conditions that violate the Food, Drug, or Cosmetic Act.
 
Though the company did not provide any details about the observations, it said that none of these observations is considered either critical or repetitive in nature.
 
Prior to this, the company had received Establishment Inspection Report (EIR) from the US health regulator, United States Food and Drug Administration (USFDA) for its Goa facility from April 3-7, 2017.

Also Read: Marksans Pharma gets EIR from USFDA for its Goa facility

Presently, the “company is highly confident of closing these expeditiously and remains committed to global standards of quality and compliance,” it said.

The site will continue to supply all approved abbreviated new drug applications (ANDAs) to the US markets. The inspection will help the company receive approval for pending ANDAs, Marksans Pharma said.

As per the USFDA, an FDA Form 483 is issued to a firm’s 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.”

Also Read: Marksans Pharma arm recalls unspecified number of Ibuprofen tablets from US



Source: with inputs
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