The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals' Injectable Facility (F-3) located at Karkhadi from 18th August, 2022 to 30th August, 2022. The USFDA issued a Form 483 with 2 observations.

None of the observations are related to data integrity and management believes that they are addressable.

The company is preparing the response to the observations, which will be submitted to the USFDA within stipulated period.

The company is committed to maintain the highest quality standards and compliance at all times.