The inspection of the facility took place between February 25 to March 6, 2019 resulting in a Form 483 with eight observations
Marksans Pharma has 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.
“The inspection of the facility took place between February 25 to March 6, 2019 resulting in a Form 483 with eight observations,” it added.
None of these observations are considered either critical or repetitive in nature, the company said.
However, it did not provide any details about the observations.
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, the company also said.
As per the USFDA, a 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.”
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