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.
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.”