As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
“None of the observations are related to data integrity and management believes that they are addressable,” it said.
The company is preparing the response to the observations, which will be submitted to the USFDA within the stipulated period, Alembic added.
In a separate filing, the company said the Brazilian Health Regulatory Agency (ANVISA) has completed a good manufacturing practice audit at API-III facility at Karakhadi without any observations for its 56 active pharmaceutical ingredients.
The inspection was conducted from March 20-24, 2023, it added.
