Alembic Pharmaceuticals receives 2 observations for Gujarat facility from USFDA

Alembic Pharmaceuticals Ltd on Friday said the US health regulator has issued a Form-483 with two minor procedural observations following inspection of its injectable and ophthalmic facility (F-3) located at Karkhadi in Gujarat. The US Food and Drug Administration (USFDA) had inspected the plant from March 16-24, 2023, the company said in a regulatory filing.

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.

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