New Delhi, Mar 24 (PTI) 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.

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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.

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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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