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Thursday, March 22, 2018

Alembic Pharma gets three observations from US FDA for Gujarat plant


















Alembic Pharmaceuticals said none of the observations are related to data integrity or repetitive in nature
Alembic Pharmaceuticals said the US health regulator has made three observations after inspecting its formulation facility in Panelav, Gujarat.
“The United States Food and Drug Administration (US FDA) has conducted an inspection at Alembic Pharmaceuticals formulation facility located at Panelav from March 12-20, 2018. This was a scheduled inspection and at the end of the inspection, the US FDA issued a form 483 with 3 observations,” the company said in a regulatory filing.
Alembic Pharmaceuticals said none of the observations are related to data integrity or repetitive in nature. “The company is preparing the response to the observations, which will be submitted to the US FDA shortly,” it added.
As per the US FDA, a Form 483 is issued to a firm’s management at the conclusion of an inspection when investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. It notifies the company’s management of objectionable conditions.

Source: Expressbpd
www.gmpviolations.com GMP News, GMP guidelines, GMP Violations, GMP warnings, GMP Trends. A Public Health Global News Portal. (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed/ experts experiences sharing.) Disclaimer: The Logos/Images & content posted here are belongs to respective to Authority / owners of firm. The Article posted under public health importance news. Please ensure the guideline as per Regulatory agencies.
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